NCT07553676 Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
| NCT ID | NCT07553676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Diamens FlexCo |
| Condition | Endometriosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-05-06 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07553676 clinical trial?
This trial is open to female participants only, aged 14 Years or older, up to 49 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07553676 currently recruiting?
Yes, NCT07553676 is actively recruiting participants. Contact the research team at marlene@diamens.org for enrollment information.
Where is the NCT07553676 trial being conducted?
This trial is being conducted at Linz, Austria, Linz, Austria, Melk, Austria, Mödling, Austria and 4 additional locations.
Who is sponsoring the NCT07553676 clinical trial?
NCT07553676 is sponsored by Diamens FlexCo. The trial plans to enroll 200 participants.