Collection of Samples USOPTIVAL Study
Start Date
12/30/2020
Completion Date
12/30/2025
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.
Detailed Description
This study is designed to prospectively collect blood samples and clinical data from subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC scheduled for resection surgery, as well as subjects who are at average-risk of colorectal cancer and who are scheduled for routine colonoscopy examination. Subjects interested in participation and who meet inclusion criteria and provide written informed consent will be enrolled in the study. By accepting participation in the study, subjects will consent to provide up to 40 ml of blood at the study visit.
Eligibility Criteria
Age Range: 45 years to 84 years
Interventions
Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel
Conditions
Locations
Precision Recearch Institute
Chula Vista, California 91910
United States
Precision Research Institute
San Diego, California 92114
United States
Medical Associates Research Group
San Diego, California 92123
United States
Clinical Research of California
Walnut Creek, California 94598
United States
Center for Gastrointestinal Disorders
Hollywood, Florida 33021
United States
Lakeland Regional Cancer Center
Lakeland, Florida 33805
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Ochsner Clinic
New Orleans, Louisiana 70121
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mid Hudson Medical Research
New Windsor, New York 12553
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Frontier Clinical Research
Uniontown, Pennsylvania 15401
United States
Clinical Trials Network
Union City, Tennessee 38261
United States
Vilo Research Group
Houston, Texas 77017
United States
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia 24014
United States