Endometriosis Biomarker Discovery Study

Withdrawn

• Conditions: Endometriosis; Chronic Pelvic Pain

• Registration Number: NCT03272360
• Lead Sponsor: Myriad Genetic Laboratories, Inc.

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.

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 Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain	Baseline (pre-operative)	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

Secondary Outcome Measures

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