Endometriosis Biomarker Discovery Study

NCT ID: NCT03272360

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Chronic Pelvic Pain; Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic Pelvic Pain

No interventions assigned to this group

Elective Tubal Ligation

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EP-002

Identifier Type: -

Identifier Source: org_study_id