NCT03272360

Endometriosis Biomarker Discovery Study

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Myriad Genetic Laboratories, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2017-09-05
• Last updated: 2017-09-05