Validation of a Non-Invasive Laboratory Test Using Menstrual Blood to Diagnose Endometriosis A Multicenter Study Involving Women Aged 14 to 49

What this Trial Is About

Endometriosis is a condition affecting at least 1 in 10 women worldwide, often diagnosed late due to the need for invasive laparoscopy. Researchers are studying a new non-invasive laboratory test that analyzes biomarkers from menstrual blood samples to diagnose endometriosis more easily. This multicenter diagnostic validation study aims to assess how well this blood-based test can identify endometriosis compared to confirmed cases and controls. Participants include menstruating women aged 14 to 49 years who are divided into groups based on their endometriosis status those with confirmed endometriosis through laparoscopy, histology, or imaging, and control groups without evidence of the disease confirmed by laparoscopy or imaging. Women self-collect menstrual blood samples, which are then analyzed for biomarkers to evaluate the tests diagnostic accuracy. Women involved in the study will provide a single menstrual blood sample within seven months after enrollment. The primary outcome measured is the diagnostic accuracy of this biomarker test, including several performance metrics such as sensitivity, specificity, and predictive values. The study is observational and conducted at multiple centers in Austria and Germany, with a planned duration of three years, including follow-up and data analysis.

Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis