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Completed

NCT Number: NCT03161704

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.

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Key information

Conditions

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

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Yale University, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 22, 2017
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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