Cedars-Sinai
PROJECT
From Biorepository to Clinical Trial: An Endometriosis Discovery
ROLE
Clinical Research Associate II
TIMELINE
June 2023 - August 2024
TEAM
Lawrenson Laboratory, Minimally Invasive Gynecologic Surgery, Gynecologic Oncology, Pathology
Site
Cedars-Sinai Medical Center, Department of Obstetrics & Gynecology
Study Design
Investigator-initiated biorepository and biomarker study
Disease Area
Endometriosis and gynecologic disease
Principal Investigator(s)
Kate Lawrenson, PhD; Kelly Wright, MD
01 Summary
I supported an investigator-initiated, longitudinal biorepository study tracking patients undergoing gynecologic surgery to identify biologic and epidemiologic markers of endometriosis. I followed patients from surgery through one year post-op, pairing questionnaires and interviews with biospecimen collection at each timepoint to link patient-reported outcomes with banked biologic data. Endometriosis takes years to diagnose, and part of the problem is that so little is understood about its underlying biology. This study was designed to change that.
CORE COMPETENCIES:
Patient Recruitment & Consent, Patient Interviewing, Biospecimen Collection & Processing, IRB/Regulatory Compliance, Biorepository Data Management
02 Approach
I identified and consented eligible surgical patients for the BEME biorepository, then followed each participant through a full year of the study. I coordinated biospecimen collection at the time of surgery and at 3-month, 6-month, and 1-year follow-up visits, working closely with surgeons and pathology to align collection with tight OR schedules. At each follow-up timepoint, I conducted patient questionnaires and interviews to capture symptom and quality-of-life data alongside the biological samples. Throughout, I maintained IRB documentation and regulatory compliance across the study's full longitudinal timeline, ensuring the biorepository stayed audit-ready from enrollment through final follow-up.
03 Impact
The study produced a publication in Fertility and Sterility examining age-related trends in endometriosis severity and surgical complexity, and contributed to a randomized controlled trial published in the American Journal of Obstetrics and Gynecology comparing insufflation pressures in laparoscopic gynecologic surgery. Separately, the study identified a significant immune finding that enabled the design of an interventional clinical trial for a novel, non-hormonal endometriosis therapeutic.
