Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 14 years — 49 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
Overview
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
Primary outcome measures
- Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis [Time frame: Single self-collected menstrual blood sampling within 7 months after enrollment.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Austria · 6 centers
- Gynlounge — Linz
- Institut für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie am Kepler Universitätsklini — Linz
- Gynäkologie und Geburtshilfe am Landesklinikum Melk — Melk
- Kinder- und Jugendgynäkologie Villa Medica Medizinisches Kompetenzzentrum GmbH — Mödling
- Wahlarztordination Puschacher — Pöggstall
- Krankenhaus der Barmherzigen Brüder Wien — Vienna
Germany · 2 centers
- Frauenklinik Städtisches Klinikum Karlsruhe — Karlsruhe
- Klinik für Frauenheilkunde und Geburtshilfe Barmherzige Brüder Klinik St. Hedwig — Regensburg
Identifiers
NCT: NCT07553676 · 1043/2025