Research OutSmarts Endometriosis II Study
Part of paid clinical trials in Manhasset, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT05601596
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- Analysis of menstrual blood to predict endometriosis — DIAGNOSTIC_TESTMenstrual blood from controls and symptomatic cases will be analyzed using single cell RNA-sequencing to develop a panel of biomarkers that can be developed into a screening test or diagnostic test for endometriosis.
Study Details
This product will be used as a diagnostic test to screen for the likelihood of endometriosis in menstruating adults with symptoms suggestive of endometriosis. The purpose of the test will be to guide clinical decisions regarding: 1) whether to undergo diagnostic laparoscopy to confirm the presence of endometriosis (currently, the gold standard for diagnosing endometriosis) and/or 2) how to guide the choice of hormonal or other therapies to treat symptoms of endometriosis.
Key Dates
- Start date
- May 27, 2022
- Status verified
- Jun 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 250 participants (estimated)
Arms
- Arm: Control ParticipantHaving No symptoms of Endo. Provide Menstrual samples.
- Arm: Symptomatic participantHaving symptoms of Endo and heading to diagnostic surgery as part of their standard of care (referred).
Primary Outcome Measure
ROSE II: Pilot study to analyze menstrual blood to predict endometriosis [ Time Frame: 2 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Feinstein Institutes/Northwell health | Manhasset | New York | 11030-3816 | - |
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