{"paper_id":"a6acb9d9-a8db-4ea0-a108-2ff2e1054801","body_text":"Validation of New GIMA Biomarker Signature of Endometriosis- Interim Data\nAuthors/Creators\n- 1. Endom etriosis and Neuroenterology Institute, 954 Ridgebrook Road, Sparks Glencoe, MD 21152 USA\n- 2. Wom an's Hospital of Texas, 7600 Fannin Street, Houston, TX 77054 USA and Gastrointestinal Consultants of Houston, 7501 Fannin St., Suite 705, Houston, TX 77054 USA\n- 3. Integrative Ayurveda Gastroenterology and Nutrition Initiative, 202, Specialty Business Center Balewadi, Pune, Maharashtra 411045 India\nDescription\nObjective: Validate diagnostic accuracy of new unique biomarker, Gastrointestinal Myoelectrical Activity (GIMA),\ndetected by Electroviscerography (EVG) with Ai-derived disease threshold score calculation to non-invasively diagnose\nendometriosis.\nDesign: Multicenter prospective blinded trial.\nSetting: Women’s healthcare center.\nPopulation of Sample: 165 patients with and without endometriosis diagnosis.\nMethods: Initial 50 patients meeting inclusion criteria in 165-patients multicenter prospective GIMA biomarker trial were\nselected for interim analysis. Study population included women 27 years-55 years old, 25 with diagnosis of endometriosis\nand 25 non-endometriosis controls. Clinical and GIMA data were collected between February 2007 and September 2017,\nat all harvesting time points and frequency bands using EVG. Ai-derived threshold score calculations used Area Under\nThe Curve (AUC), age and standardized pain scores variables.\nMain Outcome Measures: Specificity, sensitivity, NPV, PPV and predictive probability or C-statistic from logistical\nregression analyses of all AUC frequency and time points.\nResults: Non-endometriosis versus endometriosis cohort interim analysis differed significantly (p<0.001) for median\n(IQR), AUC values, and percent frequency power distribution at baseline, (10, 20, and 30) minute post water-load at\nfrequency ranges (15-20, 30-40, 40-50 and 50-60) cpm. GIMA threshold scoring revealed sensitivity and PPV of 96%,\nspecificity and NPV of 96% and C-statistic of 100%. Ai-derived GIMA biomarkers threshold scoring predicted 25/25\nsubjects positive and negative for endometriosis, with surgical confirmation. Hormonal therapy, surgical stage, age nor\npain score affected diagnostic accuracy.\nConclusion: EVG GIMA biomarker data with Ai-derived threshold scoring accurately distinguished participants with and\nwithout endometriosis. This interim analysis supports continued investigation of GIMA biomarkers to diagnose\nendometriosis.\nFiles\nmark q2 accepted file.pdf\nFiles\n(1.3 MB)\n| Name | Size | Download all |\n|---|---|---|\n|\nmd5:85e8166aba52a97b6379cb3a61dd975d\n|\n1.3 MB | Preview Download |","source_license":"CC0","license_restricted":false}