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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161704
• Other study ID #: ENDOmarker
• Status: Completed
• Start date: July 8, 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Pennsylvania State University	Hershey	Pennsylvania
United States	Yale University	New Haven	Connecticut
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Wayne State University	Southfield	Michigan

Sponsors (8)

Lead Sponsor	Collaborator
Yale University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collection of Plasma in 1 4ml EDTA tube	1 4ml EDTA tube will be drawn at each collection, up to 3 1.0ml aliquots per collection.	3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Other	Collection of Whole Blood in 2 4ml EDTA tubes	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 timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Other	Collection of Urine will be one complete sample as produced by the subject	1 urine sample will be collected each time, up to 6 15ml aliquots and 5 1.5ml aliquots per collection will be taken.	3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Primary	Collection of up to 3 2cm samples of Endometrial Tissue	Up to 3 2cm samples will be collected per collection.	2 collection timepoints: baseline and up to 18 weeks following surgery.
Secondary	Collection of Serum 1 will be 2 10ml serum tubes of serum	2 10ml serum tubes will be drawn at each collection, up to 10 1.0ml aliquots per collection.	3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.
Secondary	Collection of Serum 2 will be 2 7 ml serum tubes of serum	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.	3 collection timepoints: baseline, up to 14 days following surgery and up to 18 weeks following surgery.