Endometriosis Biomarker Discovery Study (EMBARK)

A Prospective Sample Collection Study in Patients With Pelvic Pain Undergoing Laparoscopy for Biomarker Identification in Endometriosis

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.

Study Overview

• Status: Withdrawn
• Conditions: Endometriosis; Chronic Pelvic Pain

Detailed Description

This study will be a prospective collection of blood, urine, and endometrial tissue from women with chronic pelvic pain symptoms, with or without infertility, who require evaluation by laparoscopy. Women undergoing laparoscopy for elective tubal ligation will also be investigated similarly and serve as the negative control. Subjects will be queried regarding sociodemographic characteristics, medical and reproductive history, pain and lifestyle as well as assessment for differential diagnoses such as interstitial cystitis and idiopathic bowel syndrome. Endometriosis severity will be captured by rASRM staging during laparoscopy.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women seeking care at OB/GYN clinics and fertility centers

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Prior surgical diagnosis of endometriosis.
2. Currently pregnant or breastfeeding.
3. Clinical suspicion of pelvic inflammatory disease (PID) or urinary tract infection.
4. Current malignancy except non-melanoma skin cancer adequately treated.
5. Known major systemic disease, including but not limited to inflammatory disease, autoimmune disease.
6. Use of immunosuppressants in the past 3 months.
7. Use of injectable reproductive hormonal therapy within the past 3 months and have not menstruated since last dose.
8. 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.
9. Use of intrauterine device (IUD) in the past 3 months.
10. Use of any other reproductive hormone therapy within the past 3 months, except for oral contraceptives (OCPs).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic Pelvic Pain
Elective Tubal Ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The identification of biomarker(s) that are associated with endometriosis severity	The secondary variables will be measures of endometriosis severity: rASRM staging of endometriosis and pain severity from clinical survey	Baseline (pre-operative)

Collaborators and Investigators

• Sponsor: Myriad Genetic Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (ACTUAL): September 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain
• Other Study ID Numbers: EP-002