Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
NCT ID: NCT03161704
Last Updated: 2020-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
114 participants
OBSERVATIONAL
2016-07-08
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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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.
Exclusion Criteria
* 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
18 Years
44 Years
FEMALE
Yes
Sponsors
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Augusta University
OTHER
Penn State University
OTHER
University of California, San Francisco
OTHER
University of North Carolina
OTHER
University of Oklahoma
OTHER
University of Pennsylvania
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Kurt Barnhart, MD MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Esther Eisenberg, MD MPH
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Michael Diamond, MD
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Richard Legro, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Marcelle Cedars, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Anne Steiner, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Karl Hansen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Christos Coutifaris, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Heping Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Augusta University
Augusta, Georgia, United States
Wayne State University
Southfield, Michigan, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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ENDOmarker
Identifier Type: -
Identifier Source: org_study_id
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