Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
Objective: The primary objective is to evaluate the diagnostic accuracy of a laboratory protocol for biomarker analysis from menstrual blood samples. Performance metrics including Area Under the Curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) will be assessed by comparing women with confirmed endometriosis to confirmed controls. Study
Design: This is a prospective multicenter diagnostic study. Menstrual blood samples are self-collected by participants. Participants: A total of 200 menstruating women aged 14-49 years will be enrolled across study sites. Participants are allocated to one of two cohorts. Study Sites: The study is conducted at multiple gynecological centers in Austria and Germany, with planned expansion to additional sites. Sponsor: Diamens FlexCo, Linz, Austria Expected Study Duration: 3 years
• Women aged 14 to 49
• Menstruating
• Endometriosis group
‣ Histologically confirmed endometriosis
⁃ Imaging-verified endometriosis
• Laparoscopy-negative group:
• \- Laparoscopy with no evidence of endometriosis
• Imaging-negative group:
‣ Healthy women (no symptoms of endometriosis)
⁃ Imaging shows no evidence of endometriosis