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

Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07553676

Enrollment

200

Registered

2026-04-28

Start date

2026-05-06

Completion date

2029-12-01

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

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 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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis	Single self-collected menstrual blood sampling within 7 months after enrollment.	Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of biomarkers from menstrual blood samples.

Countries

Austria, Germany

Contacts

CONTACTMarlene Rezk-Füreder CEO

marlene@diamens.org+4367764346422

Outcome results