Research OutSmarts Endometriosis II Study
Enrolling by invitation
Conditions studied: Endometriosis
In brief
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 facts
- Study ID
- NCT05601596
- Run by
- Northwell Health
- People needed
- 250
- Starts
- 2022-05-27
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- For All
- 18 to 40 year old menstruating women (continue to get cycles)
- More than a light menstrual flow (light flow is soaking less than 1 thin pad or light tampon in 4 hours at peak flow)
- Willingness to provide two menstrual samples across two separate menstrual cycles.
- Willingness to provide a DNA sample (obtained via menstrual blood or cheek swab)
- For Controls:
- General Absence of *symptoms suggestive of endometriosis which includes: 1-Chronic pelvic pain 2-Painful menses 3-Pain during intercourse 4-Pain going to the bathroom 5-Abdominal bloating (BUT MUST NOT Include): 6-Report of missed days of work, school, athletic,social and/or other activities due to related pain and discomfort
- For Symptomatic:
- Consistently Experiencing chronic symptoms of endometriosis*
- Without definitive diagnosis (i.e. pathology report following diagnostic surgery)
- Seeking physician evaluation (considered by physician to be a candidate for laproscopic surgery
- Willingness to provide at least one of the menstrual samples PRIOR to planned surgery
- Surgical and pathological confirmation of endo (or NOT)
You may not qualify if…
- For All:
- under age 18 or over 40 years
- Unable/unwilling to provide a menstrual sample
- Light menstrual flow (light flow is soaking less than 1 thin pad or light tampon in 4 hours at peak flow)
- Diagnosed with endometriosis
- CONTROL:
- More than 1 symptom of endometriosis*
- Report of missed days of work, school, athletic, social and/or other activities due to related pain and discomfort
- Symptomatic:
- Unable to provide a menstrual sample prior to surgery
Where it is running
- Feinstein Institutes/Northwell health — Manhasset, New York, United States
Full record on ClinicalTrials.gov
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