Clinical trial NCT03272360: Endometriosis Biomarker Discovery Study
Official title: A Prospective Sample Collection Study in Patients With Pelvic Pain Undergoing Laparoscopy for Biomarker Identification in Endometriosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Pelvic Pain
Endometriosis
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seeking care at OB/GYN clinics and fertility centers

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.

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).

Primary outcomes:
measure: The identification of biomarker(s) that are differentially expressed in endometriosis in the context of pelvic pain
timeFrame: Baseline (pre-operative)
Secondary outcomes:
measure: The identification of biomarker(s) that are associated with endometriosis severity
timeFrame: Baseline (pre-operative)
Other outcomes:
Locations:
Study officials:
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