Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endo
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients. This multicenter diagnostic validation study investigates a non-invasive laboratory test for the dia
| Condition(s) | Endometriosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients. This multicenter diagnostic validation study investigates a non-invasive laboratory test for the diagnosis of endometriosis based on the analysis of biomarkers from menstrual blood samples. Study 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 assesse |
| Who can participate | Inclusion criteria: * 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 Exclusion criteria: * Amenorrhea * Pregnancy * Oncological diseases * Use of GnRH agonists or antagonists |
| Ages | 14 Years to 49 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Diamens FlexCo |
| Locations | Linz, Austria; Linz, Austria; Melk, Austria; Mödling, Austria; Pöggstall, Austria; Vienna, Austria (+2 more sites) |
| Start date | 2026-05-06 |
| NCT ID | NCT07553676 |
| Official listing | https://clinicaltrials.gov/study/NCT07553676 |