Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age14-49
SponsorDiamens FlexCo
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 14 to 49
Menstruating
Endometriosis group
Histologically confirmed endometriosis
Disqualifiers
Amenorrhea
Pregnancy
Oncological diseases
Use of GnRH agonists or antagonists
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Endometriosis
Group B: Controls
Trial outcomes
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.
Time frame
Single self-collected menstrual blood sampling within 7 months after enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Diamens FlexCo
Lead sponsor
Kepler University Clinic, Linz
Collaborator
Source ClinicalTrials.gov