Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03161704
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Yale University

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.

Condition or disease
Endometriosis

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 114 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
Actual Study Start Date : July 8, 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis




Primary Outcome Measures :
  1. Collection of up to 3 2cm samples of Endometrial Tissue [ Time Frame: 2 collection timepoints: baseline and up to 18 weeks following surgery. ]
    Up to 3 2cm samples will be collected per collection.


Secondary Outcome Measures :
  1. Collection of Serum 1 will be 2 10ml serum tubes of serum [ Time Frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. ]
    2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection.

  2. Collection of Serum 2 will be 2 7 ml serum tubes of serum [ Time Frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. ]
    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.


Other Outcome Measures:
  1. Collection of Plasma in 1 4ml EDTA tube [ Time Frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. ]
    1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection.

  2. Collection of Whole Blood in 2 4ml EDTA tubes [ Time Frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. ]
    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 of Urine will be one complete sample as produced by the subject [ Time Frame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery. ]
    1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken.


Biospecimen Retention:   Samples With DNA
Collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction and urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161704


Locations
Layout table for location information
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
United States, Michigan
Wayne State University
Southfield, Michigan, United States, 48034
United States, Pennsylvania
Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Yale University
Augusta University
Penn State University
University of California, San Francisco
University of North Carolina
University of Oklahoma
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Kurt Barnhart, MD MSCE University of Pennsylvania
Study Director: Esther Eisenberg, MD MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Nanette Santoro, MD University of Colorado, Denver
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
Additional Information:

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03161704    
Other Study ID Numbers: ENDOmarker
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometriosis
Genital Diseases, Female