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

Completed

• Conditions: Endometriosis

• Registration Number: NCT03161704
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-13
• Study Start: 2016-07-08
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Primary Completion: 2019-08
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of up to 3 2cm samples of Endometrial Tissue	2 collection timepoints: baseline and up to 18 weeks following surgery.	Up to 3 2cm samples will be collected per collection.

Secondary Outcome Measures

Name	Time	Method
Collection of Serum 2 will be 2 7 ml serum tubes of serum	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.
Collection of Serum 1 will be 2 10ml serum tubes of serum	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.

Trial Locations

Locations (5)

Pennsylvania State University; 🇺🇸 Hershey, Pennsylvania, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

Wayne State University; 🇺🇸 Southfield, Michigan, United States