NCT05601596Enrolling by invitation
Research OutSmarts Endometriosis II Study
ROSE II: Pilot Study to Analyze Menstrual Blood to Predict Endometriosis
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 4 Aug 2022
- Start date
- 27 May 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Northwell Health
- Diseases
- Endometriosis
- NCT number
- NCT05601596
What you commit to
- Study type: Observational
- Planned participants: 250
- From 27 May 2022 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Age
- under age 18 or over 40 years
Other
- For All:
- 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\*
Who the study is looking for
- 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)
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Feinstein Institutes/Northwell health Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.