Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
Completed
Conditions studied: Endometriosis
In brief
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.
Key facts
- Study ID
- NCT03161704
- Run by
- Yale University
- People needed
- 114
- Starts
- 2016-07-08
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-01-06
Who can join
Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.
You may qualify 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.
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
- 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.
Where it is running
- Yale University — New Haven, Connecticut, United States
- Augusta University — Augusta, Georgia, United States
- Wayne State University — Southfield, Michigan, United States
- Pennsylvania State University — Hershey, Pennsylvania, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.