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Enrolling By Invitation
NCT05601596
Research OutSmarts Endometriosis II Study
Conditions: Endometriosis
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Enrollment: 100
Sponsor: Northwell Health
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:For All18 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 discomfortFor Symptomatic:Consistently Experiencing chronic symptoms of endometriosis*Without definitive diagnosisSeeking physician evaluation (considered by physician to be a candidate for laproscopic surgeryWillingness to provide one of the menstrual samples PRIOR to planned surgerySurgical and pathological confirmation of endo (or NOT)Exclusion Criteria:For All:under age 18 or over 40 yearsUnable/unwilling to provide a menstrual sampleLight menstrual flow (light flow is soaking less than 1 thin pad or light tampon in 4 hours at peak flow)Diagnosed with endometriosisCONTROL:More than 1 symptom of endometriosis*Report of missed days of work, school, athletic, social and/or other activities due to related pain and discomfortSymptomatic:Unable to provide a menstrual sample prior to surgery
Source: ClinicalTrials.gov (NCT05601596). StuddyBuddy aggregates publicly available trial information.