Ovarian Cancer Registry (OVAR); A study protocol for retrospective data collection in Colombian patients with ovarian cancer

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In Colombia, as in the world, its diagnosis is made in late stages due to the absence of specific symptoms of this disease. Objective The objective of the Ovarian Cancer Registry is (i) to collect clinical and histopathological data using a standardized protocol, (ii) to characterize these patients clinically and histopathological to optimize the diagnosis and treatment, to describe these clinical aspects, which will allow us to understand the clinical particularities of this disease better. Methods The Ovarian Cancer Registry is designed as a retrospective for data collection on OVAR patients. All patients under medical care at the Hospital Universitario Mayor Méderi and who have arrived in three possible routes or scenarios: (i) outpatient care, (ii) assessment in emergency services and (iii) references to the oncology service. The OVAR will have information on patients who consulted the Major Hospital from the first of January 2021 with CIE10 C56X and C482. Ethics and dissemination The University of Rosario Ethics Committee approved registry protocol V02 (08/feb/24) No. 2541-CV1830 (Bogotá, Colombia). Registry leaders acknowledge their ongoing ethical responsibilities for all research using this data. Conclusion The data from the Ovarian Cancer Registry will be instrumental in establishing optimal management strategies for OC patients, laying the groundwork for future guideline recommendations, and shaping the direction of upcoming research on the Colombian population. 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F1000Research 2025, 14 :416 ( https://doi.org/10.12688/f1000research.162773.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Ovarian Cancer Registry (OVAR); A study protocol for retrospective data collection in Colombian patients with ovarian cancer [version 1; peer review: awaiting peer review] Jairo Mendoza-Quevedo 1 , Ingrid Ballesteros-Ordonez 1 , Elizabeth Vargas Castellanos https://orcid.org/0000-0003-4007-1711 1 Jairo Mendoza-Quevedo 1 , Ingrid Ballesteros-Ordonez 1 , Elizabeth Vargas Castellanos https://orcid.org/0000-0003-4007-1711 1 PUBLISHED 08 Apr 2025 Author details Author details 1 Hospital Universitario Mayor Méderi - Universidad del Rosario, Bogotá, Colombia Jairo Mendoza-Quevedo Roles: Conceptualization, Methodology Ingrid Ballesteros-Ordonez Roles: Methodology, Writing – Review & Editing Elizabeth Vargas Castellanos Roles: Conceptualization, Methodology, Writing – Original Draft Preparation OPEN PEER REVIEW REVIEWER STATUS AWAITING PEER REVIEW Abstract Ovarian cancer is one of the leading causes of death from gynecologic cancer. In Colombia, as in the world, its diagnosis is made in late stages due to the absence of specific symptoms of this disease. Objective The objective of the Ovarian Cancer Registry is (i) to collect clinical and histopathological data using a standardized protocol, (ii) to characterize these patients clinically and histopathological to optimize the diagnosis and treatment, to describe these clinical aspects, which will allow us to understand the clinical particularities of this disease better. Methods The Ovarian Cancer Registry is designed as a retrospective for data collection on OVAR patients. All patients under medical care at the Hospital Universitario Mayor Méderi and who have arrived in three possible routes or scenarios: (i) outpatient care, (ii) assessment in emergency services and (iii) references to the oncology service. The OVAR will have information on patients who consulted the Major Hospital from the first of January 2021 with CIE10 C56X and C482. Ethics and dissemination The University of Rosario Ethics Committee approved registry protocol V02 (08/feb/24) No. 2541-CV1830 (Bogotá, Colombia). Registry leaders acknowledge their ongoing ethical responsibilities for all research using this data. Conclusion The data from the Ovarian Cancer Registry will be instrumental in establishing optimal management strategies for OC patients, laying the groundwork for future guideline recommendations, and shaping the direction of upcoming research on the Colombian population. READ ALL READ LESS Keywords Carcinoma, Ovarian Epithelial. Diagnosis, Pathology, Registries Corresponding Author(s) Elizabeth Vargas Castellanos ( [email protected] ) Close Corresponding author: Elizabeth Vargas Castellanos Competing interests: No competing interests were disclosed. Grant information: Hospital Universitario Mayor-Méderi supported this work (Institutional funding ID: A-021-2023).. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Mendoza-Quevedo J et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Mendoza-Quevedo J, Ballesteros-Ordonez I and Vargas Castellanos E. Ovarian Cancer Registry (OVAR); A study protocol for retrospective data collection in Colombian patients with ovarian cancer [version 1; peer review: awaiting peer review] . F1000Research 2025, 14 :416 ( https://doi.org/10.12688/f1000research.162773.1 ) First published: 08 Apr 2025, 14 :416 ( https://doi.org/10.12688/f1000research.162773.1 ) Latest published: 08 Apr 2025, 14 :416 ( https://doi.org/10.12688/f1000research.162773.1 ) Introduction Ovarian cancer (OC) is one of the deadliest cancers in women, with more than 207,000 deaths worldwide per year. 1 The 5-year relative survival of patients with OC is about 45%, while the 10-year relative survival is slightly lower at 35% %. 2 According to the latest Globocan report (2022), the countries with the highest incidence and mortality rates in South America are Colombia, Argentina, and Peru, which handle intermediate rates compared to global rates. Co in Colombia manages incidence rates with an ASR 6.7 (ASR 5.5-6.8) and mortality rates of ASR 4.1 (ASR 3.7-4.3) according to the latest GLOBOCAN report, with an incidence of 2.253 cases in 2022 and mortality of approximately 1,445 deaths. 1 Epithelial ovarian cancer (EOC) is heterogeneous. The World Health Organization divides ovarian cancers disease classified into benign, borderline, and malignant. 3 , 4 Malignant EOC encompasses five main histological subtypes: (i) high-grade serous ovarian cancer (70 to 80%), (ii) endometrioid (10%), (iii) clear cell (10%), (iv) mucinous (3%), and (v) low-grade serous (<5%). 3 , 5 Each subtype behaves as a distinct entity in clinical presentation, genetic mutations, and treatment response. 6 OC is a multifactorial disease that depends on genetic and non-genetic factors. Among the main genetic risk factors are hormonal, reproductive, factors associated with body mass index, histopathological and factors associated with family history. The mammary gland and the ovary are estrogen-dependent organs, therefore prolonging exposure to estrogen may increase the risk of developing cancer. The most well-known hormonal factors are related to menstruation at an early age (menarche 55 years) with relative risk between 1.2-1.3. Among the reproductive factors is nulliparity or late age (>40 years) at first birth with a relative risk of 1.2-1.7. Intake of exogenous hormones such as oral contraceptive use and hormone replacement therapies present a relative risk of ~2.0 and 1.5 respectively. The risk factor associated with obesity is presented with body mass indices >25. 7 , 8 OC is one of the most lethal gynecological cancers in the world because there is a lack of symptoms in the early stages of the disease, most women are diagnosed late, and the main treatment is based on cytoreductive surgery and adjuvant chemotherapy. Still, with the development of chemoresistance in 75% of patients, poor treatment response and reduced survival is observed. 9 For this reason, there is a critical need to generate a registry of patients with OC that provides knowledge in the characterization of the pathophysiology and behavior of this disease, in the Colombian population. The objective of the Ovarian Cancer Registry (OVAR) is (i) to collect clinical and histopathological data using a standardized protocol, (ii) to characterize these patients clinically and histopathological to optimize the diagnosis and treatment, to describe these clinical aspects will allow us to understand the clinical particularities of this disease better. Protocol Methods Status and timeline of the OVAR registry The registry protocol was approved by the Ethics Committee of the University of Rosario (CEI-UR) in February 2024 (Bogotá, Colombia) (No. 2541-CV1830). The protocol of this registry complies with national regulations (Law 23 of 1981 and Resolution 8430 of 1993 of the Ministry of Health of Colombia) and international regulations (which include the Treaty of Helsinki, CIOMS International Ethical Guidelines for Biomedical Research in Human Beings and the Taipei Declaration). The researchers acknowledge that this project falls under the category of health databases, as defined by the Declaration of Helsinki, involving the collection of patient data beyond routine clinical care. Consequently, the OVAR adheres to the ethical guidelines outlined in the Declaration of Taipei, which governs health databases and biobanks. Study design and objectives OVAR was designed as a retrospective investigation. Given the nature of this study, obtaining specific informed consent for research is not planned. Since no interventions or modifications will be made to patient care and the data collected retrospectively will be managed in strict accordance with confidentiality guidelines governing the use of clinical records, the Research Ethics Committee was requested to waive the requirement for informed consent. This waiver will enable access to conduct the necessary documentary review, limited to the data specified in this protocol and solely for academic research purposes. In Colombia, as in the world, diagnosis of OC is made in late stages due to the absence of specific symptoms of this disease, therefore, the need to characterize clinically and histopathological these patients to optimize the diagnosis and treatment, is born to describe these clinical aspects will allow us to understand the better clinical particularities of this disease. Registry population The patients to be included in the registry must have the following requirements: (i) Colombian women of legal age, treated at the Hospital Universitario Mayor Méderi (Bogotá, Colombia). (ii) Patients diagnosed with OC, International Classification of Diseases (CIE10), C56X and C482, determined from January 1, 2021. Who has the marker CA125 and diagnostic confirmation by anatomopathological study (reported in clinical history or pathology laboratory). (iii) Patients who, due to their condition, are under management by the gynecologic-oncology service of Méderi. Note: The diagnosis doesn't need to be made intra-hospital, if it has the diagnostic information mentioned in point two of the case definition. Information collection and systematization procedures The gyneco-oncology staff will identify the cases and oversee entering the data of the detected patients into a list system previously established in the institution. This base will be refined to generate a list where only patients who meet the case definition will be present for their subsequent entry to the registry. The leading group of the registry will send the list of patients to the digitizer to review medical records. The data will be obtained exclusively from the following sources: the electronic medical record systems Servinte®, Xerox, and Annarlab. Figure 1 represents the process from the entry of patients into the registry to collecting all the proposed information. Figure 1. Flow chart of the process of inclusion of patients in the OVAR registry. Study data were collected and managed using REDCap electronic data capture (EDC) tools hosted at Hospital Universitario Mayor Méderi. REDCap (Research Electronic Data Capture) ( https://project-redcap.org/ ) 10 , 11 is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources ( Table 1 ). Table 1. Overview of the main collected parameters of the OVAR Registry. Category Variables Sociodemographic variables - Birthdate - Place of birth - Diagnosis date - Diagnostic age Clinical variables - Age at first menstrual period, menopause, and childbirth - Hormone therapy (type and duration) - Number of pregnancies and births - Contraceptive method and duration of use - Blood values (CA125, CA19.9, ACE) - Medical history (background) - Treatment details - Genetic Test Pathological variables - Tumor type - Stage - Tumor grade - Immunohistochemical Markers: Estrogen, Progesterone, Her2, Ki67, Pax8, P16, WT1, P53 Statistical analysis A bivariate analysis will explore potential relationships between variables, employing the Pearson X 2 test to compare clinical characteristics with histopathology. Categorical variables will be described as frequencies, proportions or percentages using a relative risks model. For continuous variables (age, tumor size), measures of central tendency (mean, median) and dispersion (standard deviation, range) will be used depending on whether the data are normal. Most of the statistical analysis will be performed using the statistical package R-4.4.3 ( https://www.r-project.org/ ). Management of absent data: The presence of missing data for these variables will be evaluated and, if necessary, simple imputations (mean or mode) will be applied. To characterize the sample size, a descriptive analysis will be performed where continued variables with a normal distribution will be represented by their mean and SD and non- normal distributions will be represented by their median and IQR. T-tests or ANOVA will compare mean values across groups (e.g., age differences among various histological types). At the same time, logistic regression will assess the associations between clinical and histopathological characteristics. Dissemination The findings from this registry will result in an article published in an internationally indexed journal, contributing new knowledge that may benefit the global scientific and academic community in this field. Furthermore, the results will be presented at an academic event to further disseminate this knowledge among scientific associations, researchers, professional societies, healthcare institutions, universities, and academic organizations. Study status The systematization of the registered variables information is currently underway, ensuring data organization and quality for subsequent analysis. Discussion OC is one of the most lethal types of gynecologic cancer worldwide. In Colombia, as in other countries, its diagnosis is usually made in advanced stages due to the lack of specific symptoms. Therefore, there is a need to characterize patients from the clinical and histopathological points of view to optimize both diagnosis and treatment. This registry will allow us to describe the characteristics of this disease in the Colombian population and contribute to developing more effective strategies for its management. To be able to obtain information from the database of the registry would contribute to the limited knowledge about the pathophysiology of OC in our population, with updated information and quality that will allow to generate future studies (previous approval of CIMED and the CEI-UR) related with therapeutic schemes, clinical follow-up, and even broadening one knows the long-term morbidity in this population of patients. Ethics and dissemination The realization of this work complies with the national regulations (Law 23 of 1981 and Resolution 8430 of 1993 of the Ministry of Health of Colombia) 12 , 13 and international (which include the Treaty of Helsinki, CIOMS International Ethical Guidelines for Biomedical Research in Human Beings and the Taipei Declaration). Biomedical research in humans should be carried out only by qualified scientists under the supervision of a competent medical professional (art. 395). It cannot be carried out legitimately unless the importance of its objective is proportionate to the risk that runs the subject of Experimentation (art. 396). According to the nature and design of the records, no closing date of collection is stipulated. If completion of registration is considered for internal reasons of the leading group of the registry that prevents continuity to the maintenance of data collection over time, the Registry Leader will issue a letter notifying Centro de Investigaciones de Méderi (CIMED) and CEI-UR, indicating the reasons for completing the registration. Accordingly, the information will continue to be stored on the physical servers of the hospital for 15 years, counted from the date of entry of the last registration and by Resolution 839 of 2017. 14 For the leading group of the registry, having approval from the OVAR does not exempt from submitting to evaluation and approval by the CIMED and the CEI-UR any research protocol that requires as input the total or partial information of this registry, following the regular conduit already known. The research protocols derived from the registry will be built by researchers and CIMED and CEI-UR will independently analyze the risks and benefits of research protocols according to their specific particularities. The team responsible for the registry responds to the reports or follow-up meetings requested by the research center or the entity that requires them. The team will make no modifications to the registration protocol without the prior approval of CIMED and the endorsement of the ethics committee. By Law 23 of 1981, Chapter I, Article 1. 12 The leaders of the registry are clear that having this protocol approved does not exempt submission and other ethical responsibilities of the research protocols that use this registry as input. Confidentiality The members of the registry will sign confidentiality agreements with the institution to keep the information confidential. It is guaranteed that no information will be stored in any source other than that provided for this purpose (Redcap). Internal and external audits will be conducted to ensure the quality of the information record. The leading group of the registry is committed to ensuring that all research protocols utilizing data from the Ovarian Cancer Registry are based on strong ethical principles, supported by rigorous scientific and methodological foundations. These protocols will incorporate a clear social component, and objective to provide direct or indirect benefits to patients and their families. Access to the sequenced information will only be granted with the approval of CIMED and CEI-UR. The protocol, participant-level dataset, and statistical code will be made available upon reasonable request to promote transparency and scientific collaboration. Access will be granted following the approval of the corresponding ethics committees and in compliance with data protection regulations, ensuring the confidentiality and privacy of participant information. Data sharing agreements will be established as needed to safeguard ethical and legal considerations. Ethics and consent The registry protocol was approved by the CEI-UR (Bogotá, Colombia) Version 02, February 8, 2024, Number Approval. 2541-CV1830. The protocol of this registry complies with national regulations (Law 23 of 1981 and Resolution 8430 of 1993 of the Ministry of Health of Colombia) and international regulations (which include the Treaty of Helsinki, CIOMS International Ethical Guidelines for Biomedical Research in Human Beings and the Taipei Declaration). The researchers acknowledge that this project falls under the category of health databases, as defined by the Declaration of Helsinki, involving the collection of patient data beyond routine clinical care. Consequently, the OVAR adheres to the ethical guidelines outlined in the Declaration of Taipei, which governs health databases and biobanks. OVAR was designed as a retrospective protocol. Given the nature of this study, obtaining specific informed consent for research is not planned. Since no interventions or modifications will be made to patient care and the data collected retrospectively will be managed strictly with confidentiality guidelines governing the use of clinical records, the Research Ethics Committee was requested to waive the requirement for informed consent. This waiver will enable access to conduct the necessary documentary review, limited to the data specified in this protocol and solely for academic research purposes. Data availability No data are associated with this article. References 1. Bray F, Laversanne M, Sung H, et al. : Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 2024; 74 (3): 229–263. PubMed Abstract | Publisher Full Text 2. Fortner RT, Poole EM, Wentzensen NA, et al. : Ovarian cancer risk factors by histologic subtype: An analysis from the Ovarian Cancer Cohort Consortium. J. Clin. Oncol. 2016; 34 (24): 2888–2898. Publisher Full Text Reference Source 3. Howell A, Anderson AS, Clarke RB, et al. : Risk determination and prevention of breast cancer. Breast Cancer Res. 2014; 16 (5): 446. PubMed Abstract | Publisher Full Text | Free Full Text 4. Warner E: Breast-Cancer Screening. 2011; 365 : 1025–1032. Publisher Full Text 5. Petrucelli N, Daly MB, Pal T: BRCA1 y BRCA2: cáncer de mama y ovario hereditario asociado.2018; 1–38. 6. Llort G, Chirivella I, Morales R, et al. : CLINICAL GUIDES IN ONCOLOGY SEOM clinical guidelines in Hereditary Breast and ovarian cancer. Clin. Transl. Oncol. 2015; 17 : 956–961. PubMed Abstract | Publisher Full Text Reference Source 7. Park B, Sohn JY, Yoon KA, et al. : Characteristics of BRCA1/2 mutations carriers including large genomic rearrangements in high risk breast cancer patients. Breast Cancer Res. Treat. 2017; 163 (1): 139–150. PubMed Abstract | Publisher Full Text | Free Full Text 8. Coleman RL, Hennessy BT, Coleman RL, et al. : Ovarian cancer Ovarian cancer. Crit. Rev. Oncol. Hematol. 2015; 6736 (June): 433–440. Reference Source 9. Toubhans B, Gourlan AT, Telouk P, et al. : Cu isotope ratios are meaningful in ovarian cancer diagnosis. J. Trace Elem. Med. Biol. 2020; 62 (June): 126611. PubMed Abstract | Publisher Full Text 10. Harris PA, Taylor R, Thielke R, et al. : Research electronic data capture (REDCap)-A metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 2009; 42 (2): 377–381. PubMed Abstract | Publisher Full Text | Free Full Text 11. Harris PA, Taylor R, Minor BL, et al. : The REDCap consortium: Building an international community of software platform partners. J. Biomed. Inform. 2019; 95 (December 2018): 103208. PubMed Abstract | Publisher Full Text | Free Full Text 12. Congreso de la República de Colombia: Ley 23 De 1981. Congr la República Colomb. 1981; 1981 (35): 28. Reference Source 13. Colombia M de saud de: Ministerio de salud, Resolucion numero 8430 de 1993. Minist salud. 2012; 32 (4): 471–473. Reference Source 14. MSPS: Resolución 839 de 2017, MSPS. Congr Colomb. 2017; 2017 : 1–7. Reference Source Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 08 Apr 2025 ADD YOUR COMMENT Comment Author details Author details 1 Hospital Universitario Mayor Méderi - Universidad del Rosario, Bogotá, Colombia Jairo Mendoza-Quevedo Roles: Conceptualization, Methodology Ingrid Ballesteros-Ordonez Roles: Methodology, Writing – Review & Editing Elizabeth Vargas Castellanos Roles: Conceptualization, Methodology, Writing – Original Draft Preparation Competing interests No competing interests were disclosed. Grant information Hospital Universitario Mayor-Méderi supported this work (Institutional funding ID: A-021-2023).. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (1) version 1 Published: 08 Apr 2025, 14:416 https://doi.org/10.12688/f1000research.162773.1 Copyright © 2025 Mendoza-Quevedo J et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Mendoza-Quevedo J, Ballesteros-Ordonez I and Vargas Castellanos E. Ovarian Cancer Registry (OVAR); A study protocol for retrospective data collection in Colombian patients with ovarian cancer [version 1; peer review: awaiting peer review] . 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