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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Wayne State University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pennsylvania State University
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; University of Oklahoma; University of California, San Francisco; Penn State University; Augusta University; University of North Carolina
• Investigators: Study Chair: Nanette Santoro, MD, University of Colorado, Denver; Study Director: Esther Eisenberg, MD MPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Principal Investigator: Kurt Barnhart, MD MSCE, University of Pennsylvania; Principal Investigator: 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: Heping Zhang, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: ENDOmarker

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No