Research OutSmarts Endometriosis II Study
NCT05601596
· ctgov
enrolling_by_invitation
- Enrollment
- 250
- Start
- 2022-05-27
- Completion
- 2027-06-30
- Last updated
- 2026-06-05
- Has results
- False
- Countries
- United States
Conditions
Tagged with
Interventions
-
Analysis of menstrual blood to predict endometriosis
DIAGNOSTIC_TEST
Menstrual 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.
Eligibility criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine