Endometriosis Biomarker Discovery Study

NCT03272360 | Withdrawn

• 1 other identifier: EP-002
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, Single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. Patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.

Conditions

Chronic Pelvic Pain; Endometriosis

Outcome Measures

Primary Outcomes (1)

• The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain

  The primary variables will be the DiscoveryMAP analytes identified in blood and/or urine and the mRNA transcriptome in endometrial tissue. DiscoveryMAP is a comprehensive, quantitative platform of immunoassays evaluating multiple analytes in various body system categories: cytokines, chemokines, metabolic markers, hormones, growth factors, tissue remodeling proteins, angiogenesis markers, acute phase reactants, and cancer markers

  Baseline (pre-operative)

Secondary Outcomes (1)

• The identification of biomarker(s) that are associated with endometriosis severity

  Baseline (pre-operative)

Study Arms (2)

Chronic Pelvic Pain

Elective Tubal Ligation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women seeking care at OB/GYN clinics and fertility centers

You may qualify if:

• Able to give informed consent.
• Aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length).
• Undergoing a planned diagnostic or therapeutic laparoscopy for the indication of pelvic pain or for elective tubal ligation.
• One prior pregnancy for tubal ligation patients.

You may not qualify if:

• Prior surgical diagnosis of endometriosis.
• Currently pregnant or breastfeeding.
• Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.
• Current malignancy except non-melanoma skin cancer adequately treated.
• Known major systemic disease, including but not limited to inflammatory disease, autoimmune disease.
• Use of immunosuppressants in the past 3 months.
• Use of injectable reproductive hormonal therapy within the past 3 months and have not menstruated since last dose.
• If reproductive hormonal implant has been used in the past, it must have been removed \> 3 months prior to study entry and subject must have menstruated since removal.
• Use of intrauterine device (IUD) in the past 3 months.
• Use of any other reproductive hormone therapy within the past 3 months, except for oral contraceptives (OCPs).

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, whole blood, urine, and endometrial tissue

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 5, 2017
• Study Start: September 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 5, 2017

Record last verified: 2016-09