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| Name | Class |
|---|---|
| Augusta University | OTHER |
| Penn State University | OTHER |
| University of California, San Francisco | OTHER |
| University of North Carolina |
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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.
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| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of Plasma in 1 4ml EDTA tube | 1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection. | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. |
| Collection of Whole Blood in 2 4ml EDTA tubes |
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.
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Females aged 18-44 who are scheduled to undergo gynecologic surgery (laparoscopy/laparotomy). Indications for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Barnhart, MD MSCE | University of Pennsylvania | Principal Investigator |
| Esther Eisenberg, MD MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Study Director |
| Nanette Santoro, MD | University of Colorado, Denver | Study Chair |
| Michael Diamond, MD | Augusta University | Principal Investigator |
| Richard Legro, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Marcelle Cedars, MD | University of California, San Francisco | Principal Investigator |
| Anne Steiner, MD MPH | University of North Carolina | Principal Investigator |
| Karl Hansen, MD PhD | University of Oklahoma | Principal Investigator |
| Christos Coutifaris, MD PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Augusta University |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
| University of Oklahoma | OTHER |
| University of Pennsylvania | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction and urine
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. |
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. |
| 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. |
| Collection of Urine will be one complete sample as produced by the subject | 1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken. | 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. |
| Heping Zhang, PhD | Yale University | Principal Investigator |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Wayne State University | Southfield | Michigan | 48034 | United States |
| Pennsylvania State University | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| D000091662 | Genital Diseases |