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

NCT07553676 | Not Yet Recruiting

• 1 other identifier: 1043/2025
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 7

Brief 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 four cohorts: Study Sites: The study is conducted at multiple gynecological centers in Austria (Linz, Melk, Mödling) and Germany (Karlsruhe, Regensburg), with planned expansion to additional sites. Sponsor: Diamens FlexCo, Linz, Austria Expected Study Duration: 3 years

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis

  Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of biomarkers from menstrual blood samples.

  Single self-collected menstrual blood sampling within 7 months after enrollment.

Study Arms (2)

Endometriosis

Menstruating women aged 14-49 years with confirmed endometriosis, either laparoscopically/histologically verified or imaging-verified (ultrasound or MRI by an expert).

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.

Eligibility Criteria

• Age: 14 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at gynecology departments and affiliated outpatient clinics in Austria and Germany, including university hospitals, regional hospitals, and private gynecology practices.

You may qualify if:

• 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

You may not qualify if:

• Amenorrhea
• Pregnancy
• Oncological diseases
• Use of GnRH agonists or antagonists

Sponsors & Collaborators

• Diamens FlexCo: lead
• Kepler University Clinic, Linz: collaborator

Study Sites (7)

Gynlounge

Linz, Austria

Location

Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler Universitätsklinikum

Linz, Austria

Location

Gynäkologie und Geburtshilfe am Landesklinikum Melk

Melk, Austria

Location

Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbH

Mödling, Austria

Location

Wahlarztordination Puschacher

Pöggstall, Austria

Location

Frauenklinik Städtisches Klinikum Karlsruhe

Karlsruhe, Germany

Location

Klinik für Frauenheilkunde und Geburtshilfe Barmherzige Brüder Klinik St. Hedwig

Regensburg, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Menstrual blood

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Marlene Rezk-Füreder CEO

CONTACT

+4367764346422; marlene@diamens.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 28, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (5)