NCT03161704|CompletedDMC
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Sponsor study identifier
observational
114
1 country
5
Study Start
July 8, 2016
Actual (reported)Primary Completion
August 2019
Actual (reported)Study Completion
December 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2015
Actual (reported)July 8, 2016
Actual (reported)May 22, 2017
Actual (reported)August 2019
Actual (reported)December 2019
Actual (reported)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.
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.
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.
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.
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.
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.
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.
Yale University
New Haven, Connecticut, 06520, United States
Augusta University
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
Collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction and urine
Kurt Barnhart, MD MSCE
University of Pennsylvania
Esther Eisenberg, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
University of Colorado, Denver
Michael Diamond, MD
Augusta University
114 participants (actual enrollment reported by the registry).
First Submitted
November 13, 2015
First Posted
May 22, 2017
Study Start
July 8, 2016
Actual (reported)Intestinal Permeability and Endometriosis
Contact the study team to confirm eligibility.
Richard Legro, MD
Milton S. Hershey Medical Center
Marcelle Cedars, MD
University of California, San Francisco
Anne Steiner, MD MPH
University of North Carolina
Karl Hansen, MD PhD
University of Oklahoma
Christos Coutifaris, MD PhD
University of Pennsylvania
Heping Zhang, PhD
Yale University
Primary Completion
August 2019
Actual (reported)Study Completion
December 2019
Actual (reported)Last Updated
January 6, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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