Endometriosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Yale University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of up to 3 2cm samples of Endometrial Tissue | 2 collection timepoints: baseline and up to 18 weeks following surgery. | Up to 3 2cm samples will be collected per collection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Serum 1 will be 2 10ml serum tubes of serum | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. | 2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection. |
| Collection of Serum 2 will be 2 7 ml serum tubes of serum | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Collection of Plasma in 1 4ml EDTA tube | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. | 1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection. |
| Collection of Whole Blood in 2 4ml EDTA tubes | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. | 2 4ml EDTA tubes will be drawn at each collection, up to 2 4.5ml aliquots as well as 1 FTA blood spot collection card per collection. |
| Collection of Urine will be one complete sample as produced by the subject | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. | 1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken. |
Countries
United States
Outcome results
None listed