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

NCT07553676 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-05-11

No results posted yet for this study

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 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

Conditions

  • Endometriosis

Sponsors & Collaborators

  • Kepler University Clinic, Linz

    collaborator UNKNOWN

  • Diamens FlexCo

    lead INDUSTRY

Eligibility

Min Age
14 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2029-12-01
Completion
2029-12-01

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553676 on ClinicalTrials.gov