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

Yale University

Status: Completed

Conditions: Endometriosis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03161704

ENDOmarker

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.