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

NCT03161704 | Completed DMC

• 1 other identifier: ENDOmarker
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Other Outcomes (3)

• 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.

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Yale University: lead
• Augusta University: collaborator
• Penn State University: collaborator
• University of California, San Francisco: collaborator
• University of North Carolina: collaborator
• University of Oklahoma: collaborator
• University of Pennsylvania: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

Yale University

New Haven, Connecticut, 06520, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Wayne State University

Southfield, Michigan, 48034, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction and urine

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kurt Barnhart, MD MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Esther Eisenberg, MD MPH

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

  STUDY DIRECTOR

• Nanette Santoro, MD

  University of Colorado, Denver

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: May 22, 2017
• Study Start: July 8, 2016
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

US (5)