Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol

Status:	Recruiting
Conditions:	Women's Studies, Endometriosis
Therapuetic Areas:	Other, Reproductive
Healthy:	No
Age Range:	18 - 44
Updated:	1/30/2019
Start Date:	July 8, 2016
End Date:	November 2019

This study involves the prospective collection of endometrial biopsy tissue, serum, plasma,
whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not
having) endometriosis at the time of scheduled surgery. The investigators plan to enroll
approximately 500 women to validate and optimize the use of genomic classifiers alone or in
combination with serum markers (such as cytokines) as a non-surgical marker of disease.

Exclusion Criteria:

- • Currently pregnant

- Current or past diagnosis of any malignancy (with the exception of non-melanoma
skin cancer)

- Known to be HIV-positive

- Unable to give informed consent

- Unwillingness to have samples banked in Repository for future use

- Clinical evidence of active cervical infection

- Lupron (or other GRH agonist) therapy within the last 2 months (or Depo-Lupron
within the last 4 months)

- Current use of estrogen or progestin (oral, transdermal, intrauterine or ring).

o Current use is defined as use in the index menstrual cycle (since the onset of
the last menstrual period).

- Use of depo estrogen or progestin in last 3 months

- Current use of aromatase inhibitor

Inclusion Criteria:

- Women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy).

Indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of
adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy,
salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.

We found this trial at

sites

Yale University

New Haven, Connecticut 6520

(203) 432-4771