Clinical trial NCT03161704: Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
Official title: Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Augusta University
name: Penn State University
name: University of California, San Francisco
name: University of North Carolina
name: University of Oklahoma
name: University of Pennsylvania
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-22
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Collection of up to 3 2cm samples of Endometrial Tissue
timeFrame: 2 collection timepoints: baseline and up to 18 weeks following surgery.
Secondary outcomes:
measure: Collection of Serum 1 will be 2 10ml serum tubes of serum
timeFrame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
measure: Collection of Serum 2 will be 2 7 ml serum tubes of serum
timeFrame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Other outcomes:
measure: Collection of Plasma in 1 4ml EDTA tube
timeFrame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
measure: Collection of Whole Blood in 2 4ml EDTA tubes
timeFrame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
measure: Collection of Urine will be one complete sample as produced by the subject
timeFrame: 3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Southfield
country: United States
facility: Wayne State University
state: Michigan
city: Hershey
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt Barnhart, MD MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Esther Eisenberg, MD MPH
role: STUDY_DIRECTOR
affiliation: University of Colorado, Denver
name: Nanette Santoro, MD
role: STUDY_CHAIR
affiliation: Augusta University
name: Michael Diamond, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Milton S. Hershey Medical Center
name: Richard Legro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Marcelle Cedars, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Anne Steiner, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Karl Hansen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Christos Coutifaris, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Heping Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: