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Collection of Samples USOPTIVAL Study
Sponsor: Universal Diagnostics
Summary
A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.
Official title: Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance ("USOPTIVAL")
Key Details
Gender
All
Age Range
45 Years - 84 Years
Study Type
OBSERVATIONAL
Enrollment
1300
Start Date
2020-12-30
Completion Date
2025-12-30
Last Updated
2025-11-10
Healthy Volunteers
Yes
Interventions
Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Evaluate the performance of a preliminary panel of biomarkers
Locations (16)
Precision Recearch Institute
Chula Vista, California, United States
Precision Research Institute
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Clinical Research of California
Walnut Creek, California, United States
Center for Gastrointestinal Disorders
Hollywood, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Springfield Clinic
Springfield, Illinois, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mid Hudson Medical Research
New Windsor, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Frontier Clinical Research
Uniontown, Pennsylvania, United States
Clinical Trials Network
Union City, Tennessee, United States
Vilo Research Group
Houston, Texas, United States
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States