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

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.

Conditions

• Endometriosis

Sponsors & Collaborators

• Augusta University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• 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

• 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

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-07-08

Primary Completion

2019-08-31

Completion

2019-12-31

Countries

• United States

Study Locations