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

Sponsor
Diamens FlexCo
Study ID
NCT07553676
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 49 Years
Healthy Volunteers
Accepted

Study Details

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 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

Key Dates

First listed
Apr 28, 2026
Start date
May 6, 2026
Status verified
May 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Endometriosis
    Menstruating women aged 14-49 years with confirmed endometriosis, either laparoscopically/histologically verified or imaging-verified (ultrasound or MRI by an expert).
  • Arm: Controls
    Laparoscopy-Negative Control Cohort: Menstruating women aged 14-49 years in whom endometriosis was excluded by laparoscopy (no visible endometriosis lesions and/or histological exclusion). Imaging-Negative Control Cohort: Healthy menstruating women aged 14-49 years without known symptoms suggestive of endometriosis, in whom endometriosis was excluded by expert ultrasound or MRI.

Primary Outcome Measure

Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis [ Time Frame: Single self-collected menstrual blood sampling within 7 months after enrollment. ]

Central Contacts

Find similar trials

Nationwide
Endometriosis trialsWomen's health trialsFertility trials

Related Studies