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RECRUITING
NCT04792684

Collection of Samples USOPTIVAL Study

Sponsor: Universal Diagnostics

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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