Quality of care before and after initial certification at a German certified hereditary breast and ovarian cancer center

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The German Consortium for Familial Breast and Ovarian Cancer (DK-FBREK) was founded in 1996 to improve care for these patients. Certification of cancer centers, introduced in 2004, has been linked to improved survival rates and ensures adherence to evidence-based standards. This study investigates changes in care structures and quality before and after the initial certification of the HBOC center at the University Hospital Erlangen, certified from 2021 on. Methods This retrospective study analyzed patient data from January 2018 to December 2023 at the certified Hereditary Breast and Ovarian Cancer (HBOC) center at the University Hospital Erlangen. Eligibility for genetic counseling and germline testing followed the German Cancer Society criteria. After informed consent, Next Generation Sequencing (NGS) was performed, and variants were classified according to Human Genome Variation Society (HGVS) and American College of Medical Genetics and Genomics (ACMG) standards. Medical histories and genetic results were recorded in electronic case report forms. Results From 2018 to 2023, a total of 2,694 genetic tests were performed, increasing from 962 pre-certification to 1,732 post-certification (+ 180%). Testing among affected female patients doubled. Genetic testing in breast cancer patients increased from 551 to 1,104, while testing for ovarian carcinoma rose from 117 to 159. Variants of uncertain significance were identified in approximately 9% of cases during both periods. Pathogenic findings were observed in 14.3% of cases pre-certification (with 9.2% involving BRCA1/2 mutations) and 11.5% post-certification (6.4% BRCA1/2 mutations). Enrollment in the intensified surveillance program (IBCS) increased by 182.5%, accompanied by a rise in recommendations for risk-reducing surgeries. Conclusions Certification of medical institutions ensures high-quality, evidence-based patient care and increases the utilization of preventive and counseling services, particularly for HBOC. It strengthens patient trust and acceptance, even in the context of healthcare reforms. Further studies are needed to confirm the long-term impact and necessity of certification. BRCA Breast Cancer Certification Genetic Testing HBOC Ovarian Cancer Figures Figure 1 Figure 2 Figure 3 Introduction Breast cancer is the most common oncological disease among women worldwide [1]. In Germany, more than 70,000 women are diagnosed with this disease each year [2]. In approximately 10% of patients, the cancer is attributable to a genetic mutation in genes associated with hereditary breast and ovarian cancer (HBOC) [3, 4]. The development of ovarian cancer is similarly influenced by genetic alterations, which can be detected in over 25% of cases [5]. Consequently, one third of all patients with breast or ovarian cancer have a familial history of cancer [6]. To identify these patients and provide appropriate care, the German Consortium for Hereditary Breast and Ovarian Cancer (DK-FBREK) was established in 1996 [7]. Over the past three decades, comprehensive structures have been developed to offer patients optimal counselling. The clinical implications of a familial high-risk situation, either due to the detection of a pathogenic germline mutation or the presence of a significant family history indicating an elevated risk despite unremarkable germline testing, may include not only enrollment in an intensified surveillance and follow-up program (IBCS), but also recommendations for risk-reducing surgical interventions (e.g., risk-reducing bilateral mastectomy (RRBM), risk-reducing salpingo-oophorectomy (RRSO)). To ensure the quality of oncological care, breast cancer centers in Germany were first certified by a national commission in 2004 [8]. The WiZen study demonstrated that cancer patients treated in certified cancer centers exhibit improved overall survival rates [9]. These findings underscore the importance of adhering to evidence-based standards in the treatment of oncology patients. As part of the certification process, specific targets and requirements are established to ensure the necessary level of expertise [10, 11]. In addition to core data, such as genetic counseling and testing of both affected and unaffected individuals, metrics including the number of newly diagnosed breast cancer cases within the framework of the early detection program, the proportion of pathogenic mutations, and the number of initial studies conducted are systematically recorded [12]. Annual follow-up re-certifications are intended to ensure the high standards established during the initial certification and to contribute to the continuous improvement of care structures and quality within the centers [10]. From 2021 ongoing, the HBOC center at the University Hospital Erlangen was certified for the first time by the German Cancer Society. The aim of this evaluation is to determine the extent to which structural, process, and outcome quality could be influenced and to assess how care structures evolve at a certified center in the years following initial certification. Methods In 2004, a center specializing in hereditary tumor diseases in gynecology (HBOC) was established for the first time at the Department of Gynecology and Obstetrics, University Hospital Erlangen. This center was integrated into the DK-FBREK consortium in 2019. For 2021, the Center for HBOC at the University Hospital Erlangen was successfully certified by the German Cancer Society for the first time. Since then, annual re-audits have consistently ensured the maintenance of high standards of care quality, in line with the certification requirements for centers specializing in HBOC. Patient Cohort: Between January 1, 2018, and December 31, 2023, 2,694 patients presented at the HBOC center at the University Hospital Erlangen. In order to qualify for genetic counseling related to HBOC, patients must fulfill the testing criteria established by the German Cancer Society. A distinction is made between affected and unaffected individuals, whereby there may be preventive, diagnostic, or therapeutic indications for germline testing. Patients diagnosed with breast or ovarian cancer must also meet the German Cancer Society's testing criteria. Genetic testing is recommended if breast cancer is diagnosed before the age of 36, triple-negative breast cancer age cut off changed over the past or ovarian cancer before the age of 80, even in the absence of a suspicious family history. These criteria are reviewed annually and adapted based on the latest scientific evidence, resulting in changes to the testing guidelines during the study period. Following the introduction of PARP (Poly-(ADP-ribose)-Polymerase) inhibitors for the treatment of metastatic or locally advanced HER2-negative breast cancer associated with pathogenic BRCA1/2 mutations, germline testing also gained therapeutic relevance. In cases of metastatic disease or if the inclusion criteria of the OlympiA trial were met, germline testing was recommended irrespective of family history. Structured Processes: Patients eligible for genetic counseling are identified through a systematic assessment of the German Cancer Society's inclusion criteria. If the criteria are met, patients can undergo counseling at the HBOC center. The counseling is provided by trained medical personnel who have completed the DK-FBREK basic module and hold additional qualifications in specialized human genetics counseling. Upon completion of the counseling session and after obtaining written informed consent, genetic testing is initiated (Fig 1.). A blood sample is collected and analyzed using Next Generation Sequencing (NGS) technology. The specific methods employed are detailed in the molecular genetic report, which also includes information about the genes analyzed and any identified genetic alterations. More than one genetic variant could be possible. Genetic variants are tried to be classified according to the current Human Genome Variation Society (HGVS) nomenclature. In several cases, no ACMG or IARC class was available. Once the molecular genetic results are available, findings are discussed with the patient. In cases where a pathogenic or likely pathogenic variant is detected (classified as ACMG class 4 or 5), risk-reducing surgical options (e.g., mastectomy, adnexectomy) or enrollment in an intensified breast cancer surveillance (IBCS) are considered, depending on the specific gene mutation. If the variant is of uncertain significance (ACMG class 3), patients are advised to return for re-evaluation of the variant after three years. No immediate therapeutic or diagnostic measures are taken in such cases. A negative (non-pathogenic) result has no clinical implications. It should be emphasized that certain patient groups who meet the criteria for genetic testing may remain eligible for additional interventions even if their test results are negative or of uncertain significance. For instance, in Germany, breast cancer patients diagnosed before the age of 45 may participate in the IBCS program until they reach the age of 50, irrespective of genetic findings. Statistical Analyses: Patient data from the period between January 1, 2018, and December 31, 2023, at University Hospital Erlangen were collected retrospectively. Medical histories and results of human genetic testing were documented in an electronic case report form (eCRF) using Microsoft Access 365. Descriptive analyses and statistical t-tests were performed using IBM SPSS Statistics (Version 31). Results General Patient Characteristics: At the center for HBOC at the University Hospital Erlangen, a total of 2,694 clinical genetic tests were performed between 2018 and 2023. Prior to official certification (2018–2020), 962 genetic tests were conducted. Following certification (2021–2023), the number of tests increased to 1,732, representing a significant 180.0% increase (p<0,01) (Fig 2.). Between 2018 and 2020, predictive testing was carried out in 268 women, while diagnostic testing was performed in 625 women. During the same period, 54 men underwent predictive testing and 5 men received diagnostic testing. After certification, from 2021 to 2023, 372 women were tested predictively and 1,240 women diagnostically; additionally, 76 men underwent predictive testing and 10 men diagnostic testing. The median age of women undergoing predictive testing was 43.6 years between 2018 and 2020, and 44.0 years between 2021 and 2023. For affected female patients, the mean age at testing was 53.9 years during 2018–2020 and increased to 55.3 years during 2021–2023. 2018-2020 2021-2023 Unaffected individuals (n/%) Affected individuals (n/%) No information available (n/%) Unaffected individuals (n/%) Affected individuals (n/%) No information available (n/%) Total number of tests 322 630 10 448 1250 34 Gender Female 268 (83,2%) 625 (99,2%) 9 (90%) 372 (83%) 1240 (99,2%) 33 (97,1%) Male 54 (16,8%) 5 (0,8%) 1 (10%) 76 (17%) 10 (0,8%) 1 (2,9%) Age <35 years 105 (32,6%) 46 (7,3%) 2 (20%) 142 (31,7%) 72 (5,8%) 3 (8,8%) ≥35 years, <50 years 100 (31,1%) 185 (29,4%) 2 (20%) 147 (32,8%) 343 (27,4%) 2 (5,9%) ≥50 years, <70 years 105 (32,6%) 322 (51,1%) 6 (60%) 143 (31,9%) 640 (51,2%) 24 (70,6%) ≥70 years 12 (3,7%) 77 (12,2%) 0 (0%) 16 (3,6%) 195 (15,6%) 5 (14,7%) Mean age (median age) in years 43,6 (42) 53,9 (54) 47,9 (51,5) 44,0 (42) 55,3 (54) 54,5 (54,5) Tab 1. Comparison of patient characteristics: sex and age distribution between 2018–2020 and 2021–2023. Genetic Testing in Breast and Ovarian Cancer: A total of 551 patients with breast cancer or ductal carcinoma in situ (DCIS) underwent genetic testing between 2018 and 2020, compared to 1,104 patients during the period from 2021 to 2023. Diagnostic germline testing was performed in 117 patients with ovarian, fallopian tube, or primary peritoneal carcinoma between 2018 and 2020, and in 159 patients following certification from 2021 onward. In addition, starting in 2021, four patients with serous tubal intraepithelial carcinoma (STIC) were tested; none had been tested in the earlier period (2018–2020). Four patients with borderline ovarian tumors received genetic testing before certification, whereas 38 such patients were tested from 2021 onward. The number of breast cancer patients in the lowest UICC stage (stage I) who underwent genetic testing increased by 132.4% following certification (2018–2020: 188 patients; 2021–2023: 249 patients). In UICC stage II, the number of tests increased by 198.3%, and in UICC stage III by 366.7%. A total of 63 patients with ovarian cancer FIGO stage III or higher received diagnostic germline testing between 2018 and 2020, compared to 109 patients between 2021 and 2023, representing an increase of 173.0%. 2018-2020 2021-2023 Affected individuals Affected individuals Breast cancer 513 1010 Carcinoma in situ of the breast 38 94 Ovarian cancer 100 148 Fallopian tube carcinoma 7 5 STIC 0 4 Borderline ovarian tumor 4 38 Primary peritoneal carcinoma 10 6 Breast cancer/ carcinoma in situ of the breast UICC 0 27 58 UICC I 188 249 UICC II 176 349 UICC III 33 121 UICC IV 16 102 No information available 109 188 Malignancies of the ovary, fallopian tube, and primary peritoneum FIGO I 19 18 FIGO II 3 6 FIGO III 52 76 FIGO IV 11 33 No information available 29 26 **In cases of multiple tumor entities, the highest tumor stage is considered Tab. 2.: Number of patients with different cancer types undergoing genetic testing and their clinical data (tumor stage according to UICC/FIGO) in comparison between 2018–2020 and 2021–2023. Genetic findings: A total of 962 genetic tests were conducted between 2018 and 2020, and 1,732 tests between 2021 and 2023. Variants of uncertain significance (VUS) were identified in 86 cases prior to certification (8.9%) and in 168 cases after certification (9.7%). Pathogenic findings were detected in 138 patients (14.3%) during the period 2018–2020, and in 199 patients (11.5%) from 2021 to 2023. In 2018–2020, a pathogenic BRCA1/2 mutation was confirmed in 88 patients (9.2%). An additional 70 patients were found to carry a BRCA1/2 mutation, though these variants were not classified at the time of testing. Altogether, BRCA1/2 mutations were detected in 158 patients, corresponding to 16.4% of all tested cases during that period. From 2021 to 2023, a pathogenic BRCA1/2 mutation was identified in 111 patients (6.4%). Another 92 patients carried unclassified BRCA1/2 mutations. In total, BRCA1/2 mutations were observed in 203 cases, representing 11.7% of all tested patients. 2018-2020 2021-2023 Unaffected individuals (n/%) Affected individuals (n/%) No information available (n%) Unaffected individuals (n%) Affected individuals (n%) No information available (n/%) no or 1 (likely) benign variant (ACMG or IARC class 1 or 2) 205 (63,6%) 394 (62,5%) 7 (70%) 274 (61,2%) 904 (72,3%) 22 (64,7%) 1 variant of uncertain significance (ACMG or IARC class 3) 16 (5,0%) 70 (11,1%) 0 (0%) 26 (5,8%) 139 (11,1%) 3 (8,8%) 1 (likely) pathogenic finding (ACMG or IARC class 4 or 5) 20 (6,2%) 117 (18,6%) 1 (10%) 28 (6,3%) 166 (13,3%) 5 (14,7%) BRCA1/2 mutation 12 76 0 12 95 4 Non- BRCA1/2 mutation 8 41 1 16 71 1 1 genetic variant, no ACMG or IARC class available 78 (24,2%) 24 (3,8%) 2 (20%) 110 (24,6%) 10 (8,0%) 4 (11,8%) BRCA1/2 mutation 58 10 2 84 5 3 Non- BRCA1/2 mutation 20 14 0 26 5 1 2 genetic variants 3 (1,0%) 25 (4,0%) 0 (0%) 10 (2,2%) 31 (2,4%) 0 (0%) Tab. 3.: Results of germline testing conducted in 2018–2020 and 2021–2023, classified according to ACMG/IARC guidelines in unaffected and affected patients. Clinical Consequences: Between 2018 and 2020, 223 patients were enrolled in the IBCS program. Following certification, 407 patients were included, representing an increase of 182.5% (Fig. 3). After certification, enrollment of affected patients into the IBCS program increased by 205.8% compared to the pre-certification period. Among unaffected individuals, the increase amounted to 141.3%. Regarding to risk reducing surgery between 2018 and 2020, RRSO was recommended to 127 patients, and RRBM was advised for 111 patients. From 2021 to 2023, recommendations for RRSO were given to 159 patients, while 146 patients were advised to undergo RRBM. 2018-2020 2021-2023 Unaffected individuals (n%) Affected individuals (n/%) No information available (n/%) Unaffected individuals (n/%) Affected individuals (n/%) No information available (n/%) Intensified breast cancer surveillance Total Numbers 75 146 2 106 299 2 1 (likely) pathogenic BRCA1/2 mutation (ACMG or IARC class 4 or 5) 8 (10,7%) 53 (36,3%) 0 (0%) 11 (10,4%) 62 (20,7%) 1 (50%) 1 (likely) pathogenic non- BRCA1/2 mutation (ACMG or IARC class 4 or 5) 5 (6,7%) 17 (11,6%) 0 (0%) 13 (12,3%) 50 (16,7%) 0 (0%) no genetic variant or 1 non-pathogenic variant (ACMG or IARC class 1-3) 5 (6,7%) 53 (36,3%) 1 (50%) 12 (11,3%) 168 (56,2%) 0 (0%) 1 genetic variant, no ACMG or IARC class available 53 (70,7%) 10 (6,9%) 1 (50%) 63 (59,4%) 6 (2,0%) 1 (50%) 2 genetic variants 4 (5,3%) 13 (8,9%) 0 (0%) 7 (6,6%) 13 (43,4%) 0 (0%) RRSO Total Numbers 55 71 1 75 83 1 1 (likely) pathogenic BRCA1/2 mutation (ACMG or IARC class 4 or 5) 8 (14,5%) 52 (73,2%) 0 (0%) 11 (14,7%) 57 (68,7%) 1 (100%) 1 (likely) pathogenic non- BRCA1/2 mutation (ACMG or IARC class 4 or 5) 3 (5,5%) 6 (8,5%) 0 (0%) 2 (2,7%) 13 (15,6%) 0 (0%) no genetic variant or 1 non-pathogenic variant (ACMG or IARC class 1-3) 1 (1,8%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 1 genetic variant, no ACMG or IARC class available 40 (72,7%) 6 (8,5%) 1 (100%) 57 (76%) 6 (72,3%) 0 (0%) 2 genetic variants 3 (5,5%) 7 (9,8%) 0 (0%) 5 (6,6%) 8 (66,4%) 0 (0%) RRBM Total Numbers 50 60 1 69 77 0 1 (likely) pathogenic BRCA1/2 mutation (ACMG or IARC class 4 or 5) 8 (16%) 45 (75%) 0 (0%) 11 (15,9%) 59 (76,6%) 0 1 (likely) pathogenic non- BRCA1/2 mutation (ACMG or IARC class 4 or 5) 0 (0%) 1 (1,7%) 0 (0%) 2 (2,9%) 7 (9,1%) 0 no genetic variant or 1 non-pathogenic variant (ACMG or IARC class 1-3) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 1 genetic variant, no ACMG or IARC class available 39 (78%) 6 (10%) 1 (100%) 53 (76,8%) 4 (5,2%) 0 2 genetic variants 3 (6%) 8 (13,3%) 0 (0%) 3 (4,4%) 7 (9,1%) 0 Tab 4. Enrollment numbers of affected and unaffected patients in the IBCS program and the number of recommendations for risk-reducing surgeries (RRBM RRSO) compared between 2018–2020 and 2021–2023. Discussion Through the certification of oncological and non-oncological centers, patient care is intended to be safeguarded and continuously improved based on high-quality indicators [13]. The German Cancer Society has played a pioneering role in this field for many years. Designation as a certified center for hereditary breast and ovarian cancer (HBOC) has markedly increased the number of patients undergoing genetic counseling and testing at University Hospital Erlangen. Notably, more patients with advanced breast or ovarian cancer were offered the opportunity to explore additional therapeutic options through molecular diagnostics. Furthermore, unaffected individuals gained access to preventive strategies, including risk-reducing interventions and enrollment in intensified early detection programs, thereby lowering their cancer risk. Adequate oncological care requires interdisciplinary and interprofessional collaboration across internal and external networks [14]. The certification of oncological institutions ensures high-quality treatment based on evidence-based clinical guidelines and corresponding performance indicators [14, 15]. Patients treated at certified centers demonstrate improved overall and disease-free survival [9]. Numerous studies support these findings: patients with breast cancer or colorectal carcinoma treated at certified centers showed significantly improved prognosis due to adherence to standardized, quality-assured treatment protocols [8, 16-19]. Similarly, patients with head and neck tumors or pancreatic cancer achieved better outcomes in certified hospitals [20, 21]. However, patient volume alone does not appear to be the sole determinant of treatment quality. Ortmann et al. evaluated 193 certified centers for gynecologic malignancies and reported that only low-volume centers (fewer than 15 ovarian cancer cases annually) were associated with poorer patient outcomes [22]. Among centers treating more than 15 ovarian cancer cases per year, no significant differences in survival outcomes were observed, irrespective of case volume [22]. There appears to be a ceiling effect regarding case volume. A certain amount of patients are needed to ensure a high quality treatment, above a certain threshold ever more patients do not attribute to improved outcomes. To guarantee optimal care for patients with HBOC, a structured, multi-institutional model of care was initiated in Germany in 1996 [23]. Over time, this initiative expanded to more than 12 specialized centers and, in 2005, was integrated into standard healthcare services with reimbursement by statutory health insurance providers [23]. A key strength of this model is its foundation in knowledge-generating healthcare, allowing diagnostic and preventive strategies to be continuously adapted in line with emerging evidence [24]. Regular evaluations facilitate the incorporation of novel findings into clinical recommendations. Importantly, uniform quality standards are maintained across all participating sites through standardized frameworks and close inter-center collaboration, regardless of patient volume [24]. International partnerships further promote cross-border cooperation in research and clinical management [24]. Expansion of the HBOC consortium was accompanied by the development of a regional network of certified breast and gynecologic cancer centers, ensuring high-quality, guideline-based care in close proximity to patients’ homes and thereby improving accessibility and adherence [11]. Following its designation as a certified HBOC center, the University Hospital Erlangen expanded its network of collaborating gynecology clinics in the surrounding region, which contributed to increased patient referrals. More decisive, however, were the approvals of targeted therapies for early-stage breast and ovarian cancer [25, 26]. On parallel, testing criteria defined by the German Cancer Society have undergone continuous evaluation and expansion. Patients generally place high value on treatment quality, accessibility, and certification [27]. Individuals from rural regions appear particularly willing to accept longer travel distances to access specialized care [28]. Systematic strengthening of structural and outcome quality through certification processes has further enhanced trust in certified institutions. Annual evaluations ensure the maintenance of high medical standards, a factor of particular importance for oncology patients. These aspects collectively help explain the substantial increase in patient numbers observed in both genetic testing and intensified early detection programs. Nevertheless, the rise in patient numbers following official certification does not necessarily translate into improved quality but rather into increased workload and procedural demands. Intensified early detection strategies include annual breast MRI (Magnet Resonance Imaging), supplemented by mammography and ultrasound when indicated [29-31]. Breast MRI is resource-intensive, requiring significantly greater personnel and time compared to mammography. Higher patient volumes may also entail additional organizational efforts, and infrastructural measures—such as the acquisition of new radiological equipment—are often implemented with delay. Prolonged waiting times may, in turn, reduce patient satisfaction. Thus, a potential decline in quality cannot be entirely excluded. Strengths and Limitations: Within the context of health policy regulations and ongoing hospital reforms, the certification of healthcare institutions is essential. It serves to ensure patient care based on high-quality indicators. This is made possible through objectively assessed and evidence-based criteria. For the first time, the present study has investigated the impact of certification processes on the care of patients with hereditary breast and ovarian cancer. Differences in patient characteristics as well as in tumor-specific features were also identified. However, data collection was limited to a single center. Consequently, generalization to the overall German patient population is only possible to a limited extent. Further studies, particularly with regard to tumor-specific characteristics, are therefore required to provide a more comprehensive representation. Conclusion Certification helps ensure that the quality of patient care and treatment is maintained at a consistently high, evidence-based level. Patients are more likely to seek treatment at certified institutions, as they place greater trust in the expertise provided there and are even willing to accept longer travel distances. Quantitatively, certification is reflected in an increased number of patient referrals. Furthermore, additional services, particularly preventive measures for HBOC, are more frequently utilized at these centers. In times of hospital reforms and structural changes within the healthcare sector, certification of medical institutions can provide reassurance for both treating physicians and patients. Further studies are warranted to emphasize the necessity and impact of hospital certification. Abbreviations ACMG American College of Medical Genetics and Genomics BRCA Breast Cancer gene DK FBREK-German Consortium for Familial Breast and Ovarian Cancer DCIS Ductal Carcinoma in situ eCRF electronic case report forms FIGO Fédération Internationale de Gynécologie et d'Obstétrique HBOC Hereditary breast and ovarian cancer HER Human Epidermal Growth Factor Receptor HGVS Human Genome Variation Society IARC International Agency for Research on Cancer IBCS intensified breast cancer surveillance MRI Magnetic Resonance Imaging NGS Next Generation Sequencing OPD Outpatient Department PARP Poly-(ADP-ribose)-Polymerase RRBM risk-reducing bilateral mastectomy RRSO risk-reducing salpingo-oophorectomy STIC Serous Tubal Intraepithelial Carcinoma UICC Union internationale contre le cancer WiZen Wirksamkeit der Versorgung in onkologischen Zentren Declarations Author Contributions Conceptualization: Niklas Amann, Annika Krückel; data curation: Niklas Amann, Annika Krückel; formal analysis: Niklas Amann, Annika Krückel; investigation: Niklas Amann, Henrik Spannring, Annika Krückel; project administration: Niklas Amann, Annika Krückel; resources: Matthias W. Beckmann; supervision: Niklas Amann, Annika Krückel; visualization: Niklas Amann, Annika Krückel; writing - original draft: Niklas Amann, Annika Krückel; writing-review & editing: all authors. All authors have read and agreed to the published version of the manuscript. Disclosure of potential conflicts of interest N.A. received honoraria for lectures and participation in advisory boards: Gilead, Georg Thieme Verlag. N.A. also received support for attending meetings from AstraZeneca, Novartis, Pfizer; M.H. received research support from Helsinn Healthcare SA, honoraria from Lilly Deutschland GmbH, Thieme and travel support from Novartis, Lilly Deutschland GmbH, and AstraZeneca. H.S. no conflicts of interests. L.B. received support for attending meetings from AstraZeneca; J.G. no conflicts of interests. S.N. no conflicts of interests. C.M. received honoraria for research from Novartis. F.H. no conflicts of interests. C.C.H. J.G. no conflicts of interests. P.A.F received personal fees from Novartis, Pfizer, Daiichi-Sankyo, Astra Zeneca, Eisai, Merck Sharp & Dohme, Lilly, SeaGen, Roche, Agendia, Gilead, Mylan, Menarini, Veracyte, GuardantHealth, and grants from Biontech, Pfizer, Cepheid, during the conduct of the study; and Translational Research in Oncology (TRIO). M.W.B. no conflicts of interests. AK received lecture fees from Gilead and Novartis, honoria for written scientific work from Georg Thieme Verlag as well as support for attending meetings from Lilly. Funding This research received no external funding. Data availability Data that support the findings of this study are available from the corresponding author upon reasonable request. Ethics approval and consent to participate This study was approved by the ethics committee of the Faculty of Medicine at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) (ref. number 24-440-Br). All procedures were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Supplemental agreement to the study was waived due to the retrospective study design including only anonymized data analysis. There was no use of animal research within this project. Acknowledgments The present work was performed in partial fulfillment of the requirements for obtaining the degree „Dr. med.“ of H.S. References Harbeck N et al (2019) Breast cancer. Nat Rev Dis Primers 5(1):66 Tauber N et al (2025) Therapy of early breast cancer: current status and perspectives. Arch Gynecol Obstet Beckmann MW et al (1997) Hochrisikofamilien mit Mamma- und Ovarialkarzinomen: Möglichkeiten der Beratung, genetischen Analyse und Früherkennung. 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Supplementary Files Supplements.docx Cite Share Download PDF Status: Published Journal Publication published 17 Dec, 2025 Read the published version in Journal of Cancer Research and Clinical Oncology → Version 1 posted Editorial decision: Revision requested 23 Oct, 2025 Reviews received at journal 18 Oct, 2025 Reviews received at journal 16 Oct, 2025 Reviewers agreed at journal 13 Oct, 2025 Reviews received at journal 11 Oct, 2025 Reviewers agreed at journal 08 Oct, 2025 Reviewers agreed at journal 08 Oct, 2025 Reviewers agreed at journal 06 Oct, 2025 Reviewers agreed at journal 05 Oct, 2025 Reviewers invited by journal 05 Oct, 2025 Editor assigned by journal 04 Oct, 2025 Submission checks completed at journal 04 Oct, 2025 First submitted to journal 01 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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02:22:31","extension":"html","order_by":31,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":127858,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7761592/v1/a2b0bce341d6bcbfb367c07e.html"},{"id":93732361,"identity":"4ea04f7a-eb89-40b6-b009-95ce50e470a1","added_by":"auto","created_at":"2025-10-17 02:30:30","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":100805,"visible":true,"origin":"","legend":"\u003cp\u003eStructured process of genetic testing at the Hereditary Breast and Ovarian Cancer Center at the University Hospital Erlangen.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7761592/v1/52413829c9aa43796b52fca9.png"},{"id":93732360,"identity":"4e0d0663-ba75-4311-b681-af8ca2a56609","added_by":"auto","created_at":"2025-10-17 02:30:30","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":18858,"visible":true,"origin":"","legend":"\u003cp\u003eNumber of genetic tests conducted at the HBOC center at the University Hospital Erlangen from 2018 to 2023. + = significant increase in the number of genetic testings is evident following certification in 2021 (p\u0026lt;0,01).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7761592/v1/1ead6c82cdfdb7018a484b3b.png"},{"id":93730981,"identity":"a2dbcca6-9609-45d4-a86f-5b4ff29389c1","added_by":"auto","created_at":"2025-10-17 02:22:30","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":19711,"visible":true,"origin":"","legend":"\u003cp\u003eNumber of new female patients enrolled in the IBCS program due to a familial high-risk situation, stratified by affected and unaffected status, from 2018 to 2023. + = significant increase in the number of genetic testing is evident following certification in 2021 (p\u0026lt;0,02).\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7761592/v1/f4e6bc8030d1db7bc6d3bb44.png"},{"id":98815026,"identity":"c8efd67a-270a-4488-be5c-996858b9ec84","added_by":"auto","created_at":"2025-12-22 16:13:13","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":838865,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7761592/v1/a68fc0a0-356f-47ed-8bb0-0aaa0a3e723f.pdf"},{"id":93730968,"identity":"be2237af-a321-402c-ab14-5afad0356bb2","added_by":"auto","created_at":"2025-10-17 02:22:30","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":14824,"visible":true,"origin":"","legend":"","description":"","filename":"Supplements.docx","url":"https://assets-eu.researchsquare.com/files/rs-7761592/v1/3e8a9dc85dadd34cc6a2b069.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Quality of care before and after initial certification at a German certified hereditary breast and ovarian cancer center","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBreast cancer is the most common oncological disease among women worldwide [1]. In Germany, more than 70,000 women are diagnosed with this disease each year [2]. In approximately 10% of patients, the cancer is attributable to a genetic mutation in genes associated with hereditary breast and ovarian cancer (HBOC) [3, 4]. The development of ovarian cancer is similarly influenced by genetic alterations, which can be detected in over 25% of cases [5]. Consequently, one third of all patients with breast or ovarian cancer have a familial history of cancer [6].\u003c/p\u003e\n\u003cp\u003eTo identify these patients and provide appropriate care, the German Consortium for Hereditary Breast and Ovarian Cancer (DK-FBREK) was established in 1996 [7]. Over the past three decades, comprehensive structures have been developed to offer patients optimal counselling. The clinical implications of a familial high-risk situation, either due to the detection of a pathogenic germline mutation or the presence of a significant family history indicating an elevated risk despite unremarkable germline testing, may include not only enrollment in an intensified surveillance and follow-up program (IBCS), but also recommendations for risk-reducing surgical interventions (e.g., risk-reducing bilateral mastectomy (RRBM), risk-reducing salpingo-oophorectomy (RRSO)).\u003c/p\u003e\n\u003cp\u003eTo ensure the quality of oncological care, breast cancer centers in Germany were first certified by a national commission in 2004 [8]. The WiZen study demonstrated that cancer patients treated in certified cancer centers exhibit improved overall survival rates [9]. These findings underscore the importance of adhering to evidence-based standards in the treatment of oncology patients.\u003c/p\u003e\n\u003cp\u003eAs part of the certification process, specific targets and requirements are established to ensure the necessary level of expertise [10, 11]. In addition to core data, such as genetic counseling and testing of both affected and unaffected individuals, metrics including the number of newly diagnosed breast cancer cases within the framework of the early detection program, the proportion of pathogenic mutations, and the number of initial studies conducted are systematically recorded [12]. Annual follow-up re-certifications are intended to ensure the high standards established during the initial certification and to contribute to the continuous improvement of care structures and quality within the centers [10].\u003c/p\u003e\n\u003cp\u003eFrom 2021 ongoing, the HBOC center at the University Hospital Erlangen was certified for the first time by the German Cancer Society. The aim of this evaluation is to determine the extent to which structural, process, and outcome quality could be influenced and to assess how care structures evolve at a certified center in the years following initial certification.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eIn 2004, a center specializing in hereditary tumor diseases in gynecology (HBOC) was established for the first time at the Department of Gynecology and Obstetrics, University Hospital Erlangen. This center was integrated into the DK-FBREK consortium in 2019. For 2021, the Center for HBOC at the University Hospital Erlangen was successfully certified by the German Cancer Society for the first time. Since then, annual re-audits have consistently ensured the maintenance of high standards of care quality, in line with the certification requirements for centers specializing in HBOC.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003ePatient Cohort:\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBetween January 1, 2018, and December 31, 2023, 2,694 patients presented at the HBOC center at the University Hospital Erlangen. In order to qualify for genetic counseling related to HBOC, patients must fulfill the testing criteria established by the German Cancer Society. A distinction is made between affected and unaffected individuals, whereby there may be preventive, diagnostic, or therapeutic indications for germline testing. Patients diagnosed with breast or ovarian cancer must also meet the German Cancer Society\u0026apos;s testing criteria. Genetic testing is recommended if breast cancer is diagnosed before the age of 36, triple-negative breast cancer age cut off changed over the past or ovarian cancer before the age of 80, even in the absence of a suspicious family history. These criteria are reviewed annually and adapted based on the latest scientific evidence, resulting in changes to the testing guidelines during the study period.\u003c/p\u003e\n\u003cp\u003eFollowing the introduction of PARP (Poly-(ADP-ribose)-Polymerase) inhibitors for the treatment of metastatic or locally advanced HER2-negative breast cancer associated with pathogenic \u003cem\u003eBRCA1/2\u003c/em\u003e mutations, germline testing also gained therapeutic relevance. In cases of metastatic disease or if the inclusion criteria of the OlympiA trial were met, germline testing was recommended irrespective of family history.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eStructured Processes:\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePatients eligible for genetic counseling are identified through a systematic assessment of the German Cancer Society\u0026apos;s inclusion criteria. If the criteria are met, patients can undergo counseling at the HBOC center. The counseling is provided by trained medical personnel who have completed the DK-FBREK basic module and hold additional qualifications in specialized human genetics counseling.\u003c/p\u003e\n\u003cp\u003eUpon completion of the counseling session and after obtaining written informed consent, genetic testing is initiated (Fig 1.). A blood sample is collected and analyzed using Next Generation Sequencing (NGS) technology. The specific methods employed are detailed in the molecular genetic report, which also includes information about the genes analyzed and any identified genetic alterations. More than one genetic variant could be possible. Genetic variants are tried to be classified according to the current Human Genome Variation Society (HGVS) nomenclature. In several cases,\u0026nbsp;no ACMG or IARC class was available.\u003c/p\u003e\n\u003cp\u003eOnce the molecular genetic results are available, findings are discussed with the patient. In cases where a pathogenic or likely pathogenic variant is detected (classified as ACMG class 4 or 5), risk-reducing surgical options (e.g., mastectomy, adnexectomy) or enrollment in an intensified breast cancer surveillance (IBCS) are considered, depending on the specific gene mutation. If the variant is of uncertain significance (ACMG class 3), patients are advised to return for re-evaluation of the variant after three years. No immediate therapeutic or diagnostic measures are taken in such cases. A negative (non-pathogenic) result has no clinical implications. It should be emphasized that certain patient groups who meet the criteria for genetic testing may remain eligible for additional interventions even if their test results are negative or of uncertain significance. For instance, in Germany, breast cancer patients diagnosed before the age of 45 may participate in the IBCS program until they reach the age of 50, irrespective of genetic findings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eStatistical Analyses:\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePatient data from the period between January 1, 2018, and December 31, 2023, at University Hospital Erlangen were collected retrospectively. Medical histories and results of human genetic testing were documented in an electronic case report form (eCRF) using Microsoft Access 365. Descriptive analyses and statistical t-tests were performed using IBM SPSS Statistics (Version 31).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cem\u003e\u003cu\u003eGeneral Patient Characteristics:\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAt the center for HBOC at the University Hospital Erlangen, a total of 2,694 clinical genetic tests were performed between 2018 and 2023. Prior to official certification (2018\u0026ndash;2020), 962 genetic tests were conducted. Following certification (2021\u0026ndash;2023), the number of tests increased to 1,732, representing a significant 180.0% increase (p\u0026lt;0,01) (Fig 2.).\u003c/p\u003e\n\u003cp\u003eBetween 2018 and 2020, predictive testing was carried out in 268 women, while diagnostic testing was performed in 625 women. During the same period, 54 men underwent predictive testing and 5 men received diagnostic testing. After certification, from 2021 to 2023, 372 women were tested predictively and 1,240 women diagnostically; additionally, 76 men underwent predictive testing and 10 men diagnostic testing.\u003c/p\u003e\n\u003cp\u003eThe median age of women undergoing predictive testing was 43.6 years between 2018 and 2020, and 44.0 years between 2021 and 2023. For affected female patients, the mean age at testing was 53.9 years during 2018\u0026ndash;2020 and increased to 55.3 years during 2021\u0026ndash;2023.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"647\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 286px;\"\u003e\n \u003cp\u003e2018-2020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 286px;\"\u003e\n \u003cp\u003e2021-2023\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eUnaffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003eAffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eNo information available (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003eUnaffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003eAffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eNo information available (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eTotal number of tests\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e322\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e630\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e448\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e1250\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e34\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 647px;\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eFemale\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e268 (83,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e625 (99,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e9 (90%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e372 (83%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e1240 (99,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e33 (97,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eMale\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e54 (16,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e5 (0,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e1 (10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e76 (17%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e10 (0,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e1 (2,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 647px;\"\u003e\n \u003cp\u003eAge\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e\u0026lt;35 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e105 (32,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e46 (7,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e2 (20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e142 (31,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e72 (5,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e3 (8,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e\u0026ge;35 years, \u0026lt;50 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e100 (31,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e185 (29,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e2 (20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e147 (32,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e343 (27,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e2 (5,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e\u0026ge;50 years, \u0026lt;70 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e105 (32,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e322 (51,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e6 (60%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e143 (31,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e640 (51,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e24 (70,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e\u0026ge;70 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e12 (3,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e77 (12,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e16 (3,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e195 (15,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e5 (14,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eMean age (median age) in years\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e43,6 (42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e53,9 (54)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e47,9 (51,5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e44,0 (42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 91px;\"\u003e\n \u003cp\u003e55,3 (54)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e54,5 (54,5)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTab 1. Comparison of patient characteristics: sex and age distribution between 2018\u0026ndash;2020 and 2021\u0026ndash;2023.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eGenetic Testing in Breast and Ovarian Cancer:\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA total of 551 patients with breast cancer or ductal carcinoma in situ (DCIS) underwent genetic testing between 2018 and 2020, compared to 1,104 patients during the period from 2021 to 2023. Diagnostic germline testing was performed in 117 patients with ovarian, fallopian tube, or primary peritoneal carcinoma between 2018 and 2020, and in 159 patients following certification from 2021 onward. In addition, starting in 2021, four patients with serous tubal intraepithelial carcinoma (STIC) were tested; none had been tested in the earlier period (2018\u0026ndash;2020). Four patients with borderline ovarian tumors received genetic testing before certification, whereas 38 such patients were tested from 2021 onward.\u003c/p\u003e\n\u003cp\u003eThe number of breast cancer patients in the lowest UICC stage (stage I) who underwent genetic testing increased by 132.4% following certification (2018\u0026ndash;2020: 188 patients; 2021\u0026ndash;2023: 249 patients). In UICC stage II, the number of tests increased by 198.3%, and in UICC stage III by 366.7%.\u003c/p\u003e\n\u003cp\u003eA total of 63 patients with ovarian cancer FIGO stage III or higher received diagnostic germline testing between 2018 and 2020, compared to 109 patients between 2021 and 2023, representing an increase of 173.0%.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"425\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e2018-2020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e2021-2023\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003eAffected individuals\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003eAffected individuals\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eBreast cancer\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e513\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e1010\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eCarcinoma in situ of the breast\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e38\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e94\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eOvarian cancer\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e100\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e148\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eFallopian tube carcinoma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eSTIC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eBorderline ovarian tumor\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e38\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003ePrimary peritoneal carcinoma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 425px;\"\u003e\n \u003cp\u003eBreast cancer/ carcinoma in situ of the breast\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUICC 0\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e27\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e58\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUICC I\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e188\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e249\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUICC II\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e176\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e349\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUICC III\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e121\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eUICC IV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e102\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo information available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e109\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e188\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 425px;\"\u003e\n \u003cp\u003eMalignancies of the ovary, fallopian tube, and primary peritoneum\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eFIGO I\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eFIGO II\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eFIGO III\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e76\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eFIGO IV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e33\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 198px;\"\u003e\n \u003cp\u003eNo information available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 113px;\"\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e**In cases of multiple tumor entities, the highest tumor stage is considered\u003c/p\u003e\n\u003cp\u003eTab. 2.: Number of patients with different cancer types undergoing genetic testing and their clinical data (tumor stage according to UICC/FIGO) in comparison between 2018\u0026ndash;2020 and 2021\u0026ndash;2023.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eGenetic findings:\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA total of 962 genetic tests were conducted between 2018 and 2020, and 1,732 tests between 2021 and 2023. Variants of uncertain significance (VUS) were identified in 86 cases prior to certification (8.9%) and in 168 cases after certification (9.7%).\u003c/p\u003e\n\u003cp\u003ePathogenic findings were detected in 138 patients (14.3%) during the period 2018\u0026ndash;2020, and in 199 patients (11.5%) from 2021 to 2023.\u003c/p\u003e\n\u003cp\u003eIn 2018\u0026ndash;2020, a pathogenic \u003cem\u003eBRCA1/2\u003c/em\u003e mutation was confirmed in 88 patients (9.2%). An additional 70 patients were found to carry a \u003cem\u003eBRCA1/2\u003c/em\u003e mutation, though these variants were not classified at the time of testing. Altogether, \u003cem\u003eBRCA1/2\u003c/em\u003e mutations were detected in 158 patients, corresponding to 16.4% of all tested cases during that period.\u003c/p\u003e\n\u003cp\u003eFrom 2021 to 2023, a pathogenic \u003cem\u003eBRCA1/2\u003c/em\u003e mutation was identified in 111 patients (6.4%). Another 92 patients carried unclassified \u003cem\u003eBRCA1/2\u003c/em\u003e mutations. In total, \u003cem\u003eBRCA1/2\u003c/em\u003e mutations were observed in 203 cases, representing 11.7% of all tested patients.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"647\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 246px;\"\u003e\n \u003cp\u003e2018-2020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e2021-2023\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003eUnaffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003eAffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eNo information available (n%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003eUnaffected individuals (n%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003eAffected individuals (n%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003eNo information available (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eno or 1 (likely) benign variant (ACMG or IARC class 1 or 2)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e205 (63,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e394 (62,5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e7 (70%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e274 (61,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e904 (72,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e22 (64,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 variant of uncertain significance (ACMG or IARC class 3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e16 (5,0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e70 (11,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e26 (5,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e139 (11,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e3 (8,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic finding (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e20 (6,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e117 (18,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1 (10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e28 (6,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e166 (13,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e5 (14,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cul\u003e\n \u003cli\u003e\u003cem\u003eBRCA1/2\u003c/em\u003e mutation\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e95\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cul\u003e\n \u003cli\u003eNon-\u003cem\u003eBRCA1/2\u003c/em\u003e mutation\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e16\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 genetic variant, no ACMG or IARC class available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e78 (24,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e24 (3,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e2 (20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e110 (24,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e10 (8,0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e4 (11,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cul\u003e\n \u003cli\u003e\u003cem\u003eBRCA1/2\u003c/em\u003e mutation\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cul\u003e\n \u003cli\u003eNon-\u003cem\u003eBRCA1/2\u003c/em\u003e mutation\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e2 genetic variants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e3 (1,0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e25 (4,0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e10 (2,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e31 (2,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTab. 3.: Results of germline testing conducted in 2018\u0026ndash;2020 and 2021\u0026ndash;2023, classified according to ACMG/IARC guidelines in unaffected and affected patients.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eClinical Consequences:\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBetween 2018 and 2020, 223 patients were enrolled in the IBCS program. Following certification, 407 patients were included, representing an increase of 182.5% (Fig. 3).\u003c/p\u003e\n\u003cp\u003eAfter certification, enrollment of affected patients into the IBCS program increased by 205.8% compared to the pre-certification period. Among unaffected individuals, the increase amounted to 141.3%.\u003c/p\u003e\n\u003cp\u003eRegarding to risk reducing surgery between 2018 and 2020, RRSO was recommended to 127 patients, and RRBM was advised for 111 patients. From 2021 to 2023, recommendations for RRSO were given to 159 patients, while 146 patients were advised to undergo RRBM.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"647\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 246px;\"\u003e\n \u003cp\u003e2018-2020\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 241px;\"\u003e\n \u003cp\u003e2021-2023\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003eUnaffected individuals (n%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003eAffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003eNo information available (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003eUnaffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003eAffected individuals (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003eNo information available (n/%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 647px;\"\u003e\n \u003cp\u003eIntensified breast cancer surveillance\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eTotal Numbers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e146\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e106\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e299\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic \u003cem\u003eBRCA1/2\u003c/em\u003e mutation (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e8 (10,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e53 (36,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e11 (10,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e62 (20,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e1 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic non-\u003cem\u003eBRCA1/2\u003c/em\u003e mutation (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e5 (6,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e17 (11,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e13 (12,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e50 (16,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eno genetic variant or 1 non-pathogenic variant (ACMG or IARC class 1-3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e5 (6,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e53 (36,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e12 (11,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e168 (56,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 genetic variant, no ACMG or IARC class available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e53 (70,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e10 (6,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e63 (59,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e6 (2,0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e1 (50%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e2 genetic variants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e4 (5,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e13 (8,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e7 (6,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e13 (43,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 647px;\"\u003e\n \u003cp\u003eRRSO\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eTotal Numbers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic \u003cem\u003eBRCA1/2\u003c/em\u003e mutation (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e8 (14,5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e52 (73,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e11 (14,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e57 (68,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic non-\u003cem\u003eBRCA1/2\u003c/em\u003e mutation (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e3 (5,5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e6 (8,5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e2 (2,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e13 (15,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eno genetic variant or 1 non-pathogenic variant (ACMG or IARC class 1-3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e1 (1,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 genetic variant, no ACMG or IARC class available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e40 (72,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e6 (8,5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e57 (76%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e6 (72,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e2 genetic variants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e3 (5,5%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e7 (9,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e5 (6,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e8 (66,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 647px;\"\u003e\n \u003cp\u003eRRBM\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eTotal Numbers\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic \u003cem\u003eBRCA1/2\u003c/em\u003e mutation (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e8 (16%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e45 (75%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e11 (15,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e59 (76,6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 (likely) pathogenic non-\u003cem\u003eBRCA1/2\u003c/em\u003e mutation (ACMG or IARC class 4 or 5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e1 (1,7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e2 (2,9%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e7 (9,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003eno genetic variant or 1 non-pathogenic variant (ACMG or IARC class 1-3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1 genetic variant, no ACMG or IARC class available\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e39 (78%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e6 (10%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e1 (100%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e53 (76,8%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e4 (5,2%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 160px;\"\u003e\n \u003cp\u003e2 genetic variants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 87px;\"\u003e\n \u003cp\u003e3 (6%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 84px;\"\u003e\n \u003cp\u003e8 (13,3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 75px;\"\u003e\n \u003cp\u003e0 (0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 79px;\"\u003e\n \u003cp\u003e3 (4,4%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 83px;\"\u003e\n \u003cp\u003e7 (9,1%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 80px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTab 4. Enrollment numbers of affected and unaffected patients in the IBCS program and the number of recommendations for risk-reducing surgeries (RRBM RRSO) compared between 2018\u0026ndash;2020 and 2021\u0026ndash;2023.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThrough the certification of oncological and non-oncological centers, patient care is intended to be safeguarded and continuously improved based on high-quality indicators [13]. The German Cancer Society has played a pioneering role in this field for many years. Designation as a certified center for hereditary breast and ovarian cancer (HBOC) has markedly increased the number of patients undergoing genetic counseling and testing at University Hospital Erlangen. Notably, more patients with advanced breast or ovarian cancer were offered the opportunity to explore additional therapeutic options through molecular diagnostics. Furthermore, unaffected individuals gained access to preventive strategies, including risk-reducing interventions and enrollment in intensified early detection programs, thereby lowering their cancer risk.\u003c/p\u003e\n\u003cp\u003eAdequate oncological care requires interdisciplinary and interprofessional collaboration across internal and external networks [14]. The certification of oncological institutions ensures high-quality treatment based on evidence-based clinical guidelines and corresponding performance indicators [14, 15]. Patients treated at certified centers demonstrate improved overall and disease-free survival [9]. Numerous studies support these findings: patients with breast cancer or colorectal carcinoma treated at certified centers showed significantly improved prognosis due to adherence to standardized, quality-assured treatment protocols [8, 16-19]. Similarly, patients with head and neck tumors or pancreatic cancer achieved better outcomes in certified hospitals [20, 21].\u003c/p\u003e\n\u003cp\u003eHowever, patient volume alone does not appear to be the sole determinant of treatment quality. Ortmann et al. evaluated 193 certified centers for gynecologic malignancies and reported that only low-volume centers (fewer than 15 ovarian cancer cases annually) were associated with poorer patient outcomes [22]. Among centers treating more than 15 ovarian cancer cases per year, no significant differences in survival outcomes were observed, irrespective of case volume [22]. There appears to be a ceiling effect regarding case volume. A certain amount of patients are needed to ensure a high quality treatment, above a certain threshold ever more patients do not attribute to improved outcomes.\u003c/p\u003e\n\u003cp\u003eTo guarantee optimal care for patients with HBOC, a structured, multi-institutional model of care was initiated in Germany in 1996 [23]. Over time, this initiative expanded to more than 12 specialized centers and, in 2005, was integrated into standard healthcare services with reimbursement by statutory health insurance providers [23]. A key strength of this model is its foundation in knowledge-generating healthcare, allowing diagnostic and preventive strategies to be continuously adapted in line with emerging evidence [24]. Regular evaluations facilitate the incorporation of novel findings into clinical recommendations. Importantly, uniform quality standards are maintained across all participating sites through standardized frameworks and close inter-center collaboration, regardless of patient volume [24]. International partnerships further promote cross-border cooperation in research and clinical management [24].\u003c/p\u003e\n\u003cp\u003eExpansion of the HBOC consortium was accompanied by the development of a regional network of certified breast and gynecologic cancer centers, ensuring high-quality, guideline-based care in close proximity to patients\u0026rsquo; homes and thereby improving accessibility and adherence [11].\u003c/p\u003e\n\u003cp\u003eFollowing its designation as a certified HBOC center, the University Hospital Erlangen expanded its network of collaborating gynecology clinics in the surrounding region, which contributed to increased patient referrals. More decisive, however, were the approvals of targeted therapies for early-stage breast and ovarian cancer [25, 26]. On parallel, testing criteria defined by the German Cancer Society have undergone continuous evaluation and expansion. Patients generally place high value on treatment quality, accessibility, and certification [27]. Individuals from rural regions appear particularly willing to accept longer travel distances to access specialized care [28]. Systematic strengthening of structural and outcome quality through certification processes has further enhanced trust in certified institutions. Annual evaluations ensure the maintenance of high medical standards, a factor of particular importance for oncology patients. These aspects collectively help explain the substantial increase in patient numbers observed in both genetic testing and intensified early detection programs.\u003c/p\u003e\n\u003cp\u003eNevertheless, the rise in patient numbers following official certification does not necessarily translate into improved quality but rather into increased workload and procedural demands. Intensified early detection strategies include annual breast MRI (Magnet Resonance Imaging), supplemented by mammography and ultrasound when indicated [29-31]. Breast MRI is resource-intensive, requiring significantly greater personnel and time compared to mammography. Higher patient volumes may also entail additional organizational efforts, and infrastructural measures\u0026mdash;such as the acquisition of new radiological equipment\u0026mdash;are often implemented with delay. Prolonged waiting times may, in turn, reduce patient satisfaction. Thus, a potential decline in quality cannot be entirely excluded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrengths and Limitations:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWithin the context of health policy regulations and ongoing hospital reforms, the certification of healthcare institutions is essential. It serves to ensure patient care based on high-quality indicators. This is made possible through objectively assessed and evidence-based criteria. For the first time, the present study has investigated the impact of certification processes on the care of patients with hereditary breast and ovarian cancer. Differences in patient characteristics as well as in tumor-specific features were also identified. However, data collection was limited to a single center. Consequently, generalization to the overall German patient population is only possible to a limited extent. Further studies, particularly with regard to tumor-specific characteristics, are therefore required to provide a more comprehensive representation.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eCertification helps ensure that the quality of patient care and treatment is maintained at a consistently high, evidence-based level. Patients are more likely to seek treatment at certified institutions, as they place greater trust in the expertise provided there and are even willing to accept longer travel distances. Quantitatively, certification is reflected in an increased number of patient referrals. Furthermore, additional services, particularly preventive measures for HBOC, are more frequently utilized at these centers. In times of hospital reforms and structural changes within the healthcare sector, certification of medical institutions can provide reassurance for both treating physicians and patients. Further studies are warranted to emphasize the necessity and impact of hospital certification.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eACMG\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eAmerican College of Medical Genetics and Genomics\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eBRCA\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eBreast Cancer gene\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eDK\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eFBREK-German Consortium for Familial Breast and Ovarian Cancer\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eDCIS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eDuctal Carcinoma in situ\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eeCRF\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eelectronic case report forms\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eFIGO\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eF\u0026eacute;d\u0026eacute;ration Internationale de Gyn\u0026eacute;cologie et d'Obst\u0026eacute;trique\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eHBOC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHereditary breast and ovarian cancer\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eHER\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHuman Epidermal Growth Factor Receptor\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eHGVS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHuman Genome Variation Society\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eIARC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eInternational Agency for Research on Cancer\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eIBCS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eintensified breast cancer surveillance\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eMRI\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eMagnetic Resonance Imaging\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eNGS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eNext Generation Sequencing\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eOPD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eOutpatient Department\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003ePARP\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003ePoly-(ADP-ribose)-Polymerase\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRRBM\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003erisk-reducing bilateral mastectomy\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRRSO\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003erisk-reducing salpingo-oophorectomy\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eSTIC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eSerous Tubal Intraepithelial Carcinoma\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eUICC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eUnion internationale contre le cancer\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eWiZen\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eWirksamkeit der Versorgung in onkologischen Zentren\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contributions\u003c/h2\u003e\n\u003cp\u003eConceptualization: Niklas Amann, Annika Kr\u0026uuml;ckel; data curation: Niklas Amann, Annika Kr\u0026uuml;ckel; formal analysis: Niklas Amann, Annika Kr\u0026uuml;ckel; investigation: Niklas Amann, Henrik Spannring, Annika Kr\u0026uuml;ckel; project administration: Niklas Amann, Annika Kr\u0026uuml;ckel; resources: Matthias W. Beckmann; supervision: Niklas Amann, Annika Kr\u0026uuml;ckel; visualization: Niklas Amann, Annika Kr\u0026uuml;ckel; writing - original draft: Niklas Amann, Annika Kr\u0026uuml;ckel; writing-review \u0026amp; editing: all authors. All authors have read and agreed to the published version of the manuscript.\u003c/p\u003e\n\u003ch2\u003eDisclosure of potential conflicts of interest\u003c/h2\u003e\n\u003cp\u003eN.A. received honoraria for lectures and participation in advisory boards: Gilead, Georg Thieme Verlag. N.A. also received support for attending meetings from AstraZeneca, Novartis, Pfizer; M.H. received research support from Helsinn Healthcare SA, honoraria from Lilly Deutschland GmbH, Thieme and travel support from Novartis, Lilly Deutschland GmbH, and AstraZeneca. H.S. no conflicts of interests. L.B. received support for attending meetings from AstraZeneca; J.G. no conflicts of interests. S.N. no conflicts of interests. C.M. received honoraria for research from Novartis. F.H. no conflicts of interests. C.C.H. J.G. no conflicts of interests. P.A.F received personal fees from Novartis, Pfizer, Daiichi-Sankyo, Astra Zeneca, Eisai, Merck Sharp \u0026amp; Dohme, Lilly, SeaGen, Roche, Agendia, Gilead, Mylan, Menarini, Veracyte, GuardantHealth, and grants from Biontech, Pfizer, Cepheid, during the conduct of the study; and Translational Research in Oncology (TRIO). M.W.B. no conflicts of interests. AK received lecture fees from Gilead and Novartis, honoria for written scientific work from Georg Thieme Verlag as well as support for attending meetings from Lilly.\u003c/p\u003e\n\u003ch2\u003eFunding\u003c/h2\u003e\n\u003cp\u003eThis research received no external funding.\u003c/p\u003e\n\u003ch2\u003eData availability\u003c/h2\u003e\n\u003cp\u003eData that support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003ch2\u003eEthics approval and consent to participate\u003c/h2\u003e\n\u003cp\u003eThis study was approved by the ethics committee of the Faculty of Medicine at Friedrich-Alexander-Universit\u0026auml;t Erlangen-N\u0026uuml;rnberg (FAU) (ref. number 24-440-Br). All procedures were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Supplemental agreement to the study was waived due to the retrospective study design including only anonymized data analysis. There was no use of animal research within this project.\u003c/p\u003e\n\u003ch2\u003eAcknowledgments\u003c/h2\u003e\n\u003cp\u003eThe present work was performed in partial fulfillment of the requirements for obtaining the degree \u0026bdquo;Dr. med.\u0026ldquo; of H.S.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHarbeck N et al (2019) Breast cancer. Nat Rev Dis Primers 5(1):66\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTauber N et al (2025) Therapy of early breast cancer: current status and perspectives. Arch Gynecol Obstet\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBeckmann MW et al (1997) Hochrisikofamilien mit Mamma- und Ovarialkarzinomen: M\u0026ouml;glichkeiten der Beratung, genetischen Analyse und Fr\u0026uuml;herkennung. Dtsch Arztebl Int 94(4):161\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAtaseven B et al (2020) Prevalence of BRCA1 and BRCA2 Mutations in Patients with Primary Ovarian Cancer \u0026ndash; Does the German Checklist for Detecting the Risk of Hereditary Breast and Ovarian Cancer Adequately Depict the Need for Consultation? Geburtshilfe Frauenheilkd 80(09):932\u0026ndash;940\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHarter P et al (2017) Prevalence of deleterious germline variants in risk genes including BRCA1/2 in consecutive ovarian cancer patients (AGO-TR-1). PLoS ONE 12(10):e0186043\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKast K et al (2016) Prevalence of \u0026lt;\u0026thinsp;em\u0026thinsp;\u0026gt;\u0026thinsp;BRCA1/2\u0026thinsp;germline mutations in 21 401 families with breast and ovarian cancer. J Med Genet 53(7):465\u0026ndash;471\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKlein K et al (2024) Fr\u0026uuml;hzeitige Identifikation einer famili\u0026auml;ren Krebsbelastung. Forum 39(4):285\u0026ndash;288\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBeckmann MW et al (2011) Quality assured health care in certified breast centers and improvement of the prognosis of breast cancer patients. Onkologie 34(7):362\u0026ndash;367\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSchmitt J et al (2023) Initial Cancer Treatment in Certified Versus Non-Certified Hospitals. Dtsch Arztebl Int 120(39):647\u0026ndash;654\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWesselmann S, Beckmann MW, Winter A (2014) The concept of the certification system of the German Cancer Society and its impact on gynecological cancer care. Arch Gynecol Obstet 289(1):7\u0026ndash;12\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKowalski C et al (2017) Shifting cancer care towards Multidisciplinarity: the cancer center certification program of the German cancer society. BMC Cancer 17(1):850\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDKG (2025) \u003cem\u003eJahresbericht der zertifizierten Zentren f\u0026uuml;r famili\u0026auml;ren Brust-und Eierstockkrebs - Kennzahlenauswertung 2025.\u003c/em\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBeckmann MW et al (2007) Onkologie Dreistufenmodell optimiert Behandlung unter Kostendeckung Wie die k\u0026uuml;nftigen Strukturen der onkologischen Versorgung in Deutschland aussehen sollten. Dtsch Arztebl Int 104(44):\u0026ndash;6996\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWesselmann S, Benz S, Graeven U (2014) Qualit\u0026auml;tssicherung in der Onkologie \u0026mdash; zertifizierte Netzwerke f\u0026uuml;r Patienten. Z f\u0026uuml;r Allgemeinmedizin 90(11):464\u0026ndash;468\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDeckert S et al (2021) [Methodological Standard for the Development of Quality Indicators within Clinical Practice Guidelines - Results of a structured consensus process]. Z Evid Fortbild Qual Gesundhwes 160:21\u0026ndash;33\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBierbaum V et al (2024) Treatment in certified cancer centers is related to better survival in patients with colon and rectal cancer: evidence from a large German cohort study. World J Surg Oncol 22(1):11\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJacob A et al (2021) Association of certification, improved quality and better oncological outcomes for rectal cancer in a specialized colorectal unit. Int J Colorectal Dis 36(3):517\u0026ndash;533\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKreienberg R, W\u0026ouml;ckel A, Wischnewsky M (2018) Highly significant improvement in guideline adherence, relapse-free and overall survival in breast cancer patients when treated at certified breast cancer centres: An evaluation of 8323 patients. Breast 40:54\u0026ndash;59\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKowalski C et al (2012) The Patients' View On Accredited Breast Cancer Centers: Strengths and Potential for Improvement. Geburtshilfe Frauenheilkd 72(2):137\u0026ndash;143\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eModabber A et al (2021) Impact of quality certification of multidisciplinary head and neck tumor centers. Cost Eff Resour Alloc 19(1):20\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRoessler M et al (2022) Is treatment in certified cancer centers related to better survival in patients with pancreatic cancer? Evidence from a large German cohort study. BMC Cancer 22(1):621\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOrtmann O et al (2025) Correlation of surgical volume in gynecological cancer centers with the quality of ovarian cancer care. J Cancer Res Clin Oncol 151(8):239\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSchmutzler K et al (2005) Famili\u0026auml;rer Brust- und Eierstockkrebs: Von der Forschung zur Regelversorgung. Dtsch Arztebl Int 102(50):\u0026ndash;6514\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKast K et al (2020) Famili\u0026auml;rer Brust- und Eierstockkrebs: Zielgerichtete und abgestufte Pr\u0026auml;ventionsstrategien. Dtsch Arztebl Int 117(Onkologie 3):\u0026ndash;22\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRay-Coquard I et al (2019) Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med 381(25):2416\u0026ndash;2428\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTutt ANJ et al (2021) \u003cem\u003eAdjuvant Olaparib for Patients with \u0026lt;\u0026thinsp;i\u0026thinsp;\u0026gt;\u0026thinsp;BRCA1\u003c/em\u003e- or \u0026lt;\u0026thinsp;i\u0026thinsp;\u0026gt;\u0026thinsp;BRCA2-Mutated Breast Cancer. New England Journal of Medicine, 384(25): pp. 2394\u0026ndash;2405\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLux MP et al (2011) The era of centers: the influence of establishing specialized centers on patients\u0026rsquo; choice of hospital. Arch Gynecol Obstet 283(3):559\u0026ndash;568\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSchirrmacher R, Rieger B, Justenhoven C (2022) Behandlung in zertifizierten Lungenzentren (DKG) \u0026ndash; Entscheidungsfaktoren von Patienten mit Lungenkrebs. Pneumologie 76(08):547\u0026ndash;551\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBick U (2021) Intensivierte Fr\u0026uuml;herkennung mittels Magnetresonanztomographie in der Hochrisikosituation. Radiologe 61(2):150\u0026ndash;158\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBick U et al (2019) High-risk breast cancer surveillance with MRI: 10-year experience from the German consortium for hereditary breast and ovarian cancer. Breast Cancer Res Treat 175(1):217\u0026ndash;228\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMadorsky-Feldman D et al (2016) An international survey of surveillance schemes for unaffected BRCA1 and BRCA2 mutation carriers. Breast Cancer Res Treat 157(2):319\u0026ndash;327\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-cancer-research-and-clinical-oncology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jocr","sideBox":"Learn more about [Journal of Cancer Research and Clinical Oncology](https://www.springer.com/journal/432)","snPcode":"432","submissionUrl":"https://submission.nature.com/new-submission/432/3","title":"Journal of Cancer Research and Clinical Oncology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"BRCA, Breast Cancer, Certification, Genetic Testing, HBOC, Ovarian Cancer","lastPublishedDoi":"10.21203/rs.3.rs-7761592/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7761592/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eIntroduction\u003c/b\u003e\u003c/p\u003e\u003cp\u003eGenetic mutations contribute to around 10% of breast and 25% of ovarian cancers, with one third of patients having a familial cancer history. The German Consortium for Familial Breast and Ovarian Cancer (DK-FBREK) was founded in 1996 to improve care for these patients. Certification of cancer centers, introduced in 2004, has been linked to improved survival rates and ensures adherence to evidence-based standards. This study investigates changes in care structures and quality before and after the initial certification of the HBOC center at the University Hospital Erlangen, certified from 2021 on.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis retrospective study analyzed patient data from January 2018 to December 2023 at the certified Hereditary Breast and Ovarian Cancer (HBOC) center at the University Hospital Erlangen. Eligibility for genetic counseling and germline testing followed the German Cancer Society criteria. After informed consent, Next Generation Sequencing (NGS) was performed, and variants were classified according to Human Genome Variation Society (HGVS) and American College of Medical Genetics and Genomics (ACMG) standards. Medical histories and genetic results were recorded in electronic case report forms.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e\u003cp\u003eFrom 2018 to 2023, a total of 2,694 genetic tests were performed, increasing from 962 pre-certification to 1,732 post-certification (+\u0026thinsp;180%). Testing among affected female patients doubled. Genetic testing in breast cancer patients increased from 551 to 1,104, while testing for ovarian carcinoma rose from 117 to 159. Variants of uncertain significance were identified in approximately 9% of cases during both periods. Pathogenic findings were observed in 14.3% of cases pre-certification (with 9.2% involving \u003cem\u003eBRCA1/2\u003c/em\u003e mutations) and 11.5% post-certification (6.4% \u003cem\u003eBRCA1/2\u003c/em\u003e mutations). Enrollment in the intensified surveillance program (IBCS) increased by 182.5%, accompanied by a rise in recommendations for risk-reducing surgeries.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e\u003cp\u003eCertification of medical institutions ensures high-quality, evidence-based patient care and increases the utilization of preventive and counseling services, particularly for HBOC. It strengthens patient trust and acceptance, even in the context of healthcare reforms. Further studies are needed to confirm the long-term impact and necessity of certification.\u003c/p\u003e","manuscriptTitle":"Quality of care before and after initial certification at a German certified hereditary breast and ovarian cancer center","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-17 02:22:25","doi":"10.21203/rs.3.rs-7761592/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-10-23T13:51:01+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-18T09:35:06+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-16T16:13:57+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"202297783582658293870817963700010341922","date":"2025-10-13T09:01:42+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-11T23:17:31+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"149638098808438020472233309239411355720","date":"2025-10-08T10:03:30+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"171394836088730296643521340292478490443","date":"2025-10-08T05:45:21+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"64540492811589055414384561409840886339","date":"2025-10-06T08:16:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"101322741356303050574730704357612639894","date":"2025-10-05T19:31:55+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-05T18:36:59+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-04T06:43:06+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-04T06:41:33+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Cancer Research and Clinical Oncology","date":"2025-10-01T17:28:14+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-cancer-research-and-clinical-oncology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jocr","sideBox":"Learn more about [Journal of Cancer Research and Clinical Oncology](https://www.springer.com/journal/432)","snPcode":"432","submissionUrl":"https://submission.nature.com/new-submission/432/3","title":"Journal of Cancer Research and Clinical Oncology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"35a714e9-e4d1-4075-96f0-65b304797b7b","owner":[],"postedDate":"October 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T16:08:26+00:00","versionOfRecord":{"articleIdentity":"rs-7761592","link":"https://doi.org/10.1007/s00432-025-06388-3","journal":{"identity":"journal-of-cancer-research-and-clinical-oncology","isVorOnly":false,"title":"Journal of Cancer Research and Clinical Oncology"},"publishedOn":"2025-12-17 15:57:55","publishedOnDateReadable":"December 17th, 2025"},"versionCreatedAt":"2025-10-17 02:22:25","video":"","vorDoi":"10.1007/s00432-025-06388-3","vorDoiUrl":"https://doi.org/10.1007/s00432-025-06388-3","workflowStages":[]},"version":"v1","identity":"rs-7761592","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7761592","identity":"rs-7761592","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}