Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Diamens FlexCo
- Enrollment
- 200
- Locations
- 7
- Primary Endpoint
- Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis
Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 14 Years to 49 Years (Child, Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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.
Outcomes
Primary Outcomes
Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported