RNA Assays for Endometriosis Detection and Diagnosis
Part of paid clinical trials in Branford, Connecticut.
- Sponsor
- Wren Laboratories LLC
- Study ID
- NCT06907303
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 20 Years - 35 Years
- Healthy Volunteers
- Not accepted
Interventions
- EndoDx — DIAGNOSTIC_TESTPCR assay for Endometriosis diagnosis
Study Details
Endometriosis is a common disease that affects up to 10% of women of reproductive age. Diagnosis, however, is typically delayed (up to 12 years) and is usually made after surgery. A key unmet need therefore is an accurate biomarker that can be used to detect the disease early. This study is a prospective trial to identify candidate mRNA-markers which can be used to aid in the diagnosis of this disease. It is a discovery/validation study that will identify and confirm a gene expression panel that is specific for endometriosis and provides a non-invasive tool for future use.
Key Dates
- Start date
- Jan 1, 2024
- Status verified
- Mar 2025
- Primary completion
- Aug 31, 2025
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: EndometriosisWomen with suspected endometriosis undergoing laparoscopy to provide tissue for pathological diagnosis of the disease.
- Arm: ControlWomen undergoing surgery for benign cervical disease.
Primary Outcome Measure
Develop a gene signature that detects endometriosis [ Time Frame: 12-18 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wren Laboratories | Branford | Connecticut | 06405 | - |
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