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

Status: Completed
Location: See all (5) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 44
Healthy Volunteers: t
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• 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.

Locations
United States
Connecticut
Yale University
New Haven
Georgia
Augusta University
Augusta
Michigan
Wayne State University
Southfield
Pennsylvania
Pennsylvania State University
Hershey
University of Pennsylvania
Philadelphia
Time Frame
Start Date: 2016-07-08
Completion Date: 2019-12
Participants
Target number of participants: 114
Related Therapeutic Areas
Sponsors
Collaborators: University of North Carolina, University of Oklahoma, Augusta University, Penn State University, University of California, San Francisco, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania
Leads: Yale University

This content was sourced from clinicaltrials.gov