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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometriosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of up to 3 2cm samples of Endometrial Tissue | Up to 3 2cm samples will be collected per collection. | 2 collection timepoints: baseline and up to 18 weeks following surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of Serum 1 will be 2 10ml serum tubes of serum | 2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection. | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. | 
| Collection of Serum 2 will be 2 7 ml serum tubes of serum | 2 7ml serum tubes drawn at each collection, up to 10 1.0ml aliquots of serum plus 1 15ml conical tube with the 2 blood clots per collection. | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. |