Research OutSmarts Endometriosis II Study

Plain-language summary

This is an observational study that evaluates the analysis of menstrual blood to help predict endometriosis (growth of tissue similar to the uterine lining outside the uterus). Menstruating women aged 18 to 40 may take part, including both symptomatic and symptom-free (control) groups. It is a non-interventional (observational) study and is enrolling by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

Northwell Health

Intervention

Analysis of menstrual blood to predict endometriosis

Start date

5/27/2022

Estimated completion

6/30/2027

Countries

United States

Related genes

Locations

• Manhasset, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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