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