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Eligibility
for females ages 18–44
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

Keywords

Endometriosis

Eligibility

You can join if…

Open to females ages 18–44

  • • 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

You CAN'T join if...

  • 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.

Locations

  • University of Oklahoma not yet accepting patients
    Oklahoma City, Oklahoma, 73104, United States
  • Wayne State University not yet accepting patients
    Southfield, Michigan, 48034, United States
  • Augusta University not yet accepting patients
    Augusta, Georgia, 30912, United States
  • University of North Carolina not yet accepting patients
    Chapel Hill, North Carolina, 27599, United States
  • Pennsylvania State University accepting new patients
    Hershey, Pennsylvania, 17033, United States
  • University of Pennsylvania not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT03161704
Study Type
Observational [Patient Registry]
Last Updated
May 1, 2017
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