RecruitingNCT04792684

Collection of Samples USOPTIVAL Study

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")

Sponsor

Universal Diagnostics

Enrollment

1,300 participants

Start Date

Dec 30, 2020

Study Type

OBSERVATIONAL

Conditions

Colorectal Cancer (CRC)Advanced Adenomas (AA)

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.

Eligibility

Min Age: 45 YearsMax Age: 84 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting blood and tissue samples to develop a non-invasive test (using stool or blood) for detecting colorectal cancer (CRC) and advanced pre-cancerous polyps in the colon. Two groups are being enrolled: people scheduled for colorectal cancer surgery, and people undergoing routine colonoscopy screening. **You may be eligible if...** - You are between 45 and 84 years old - You have a suspected advanced colon polyp or a newly diagnosed colorectal cancer not yet treated, scheduled for surgery, OR - You are willing to undergo a standard colonoscopy screening - You are able to give written consent **You may NOT be eligible if...** - You have already been treated for colorectal cancer - You are outside the 45–84 age range - You are unable to consent or follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOptimization 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

View Full Details on ClinicalTrials.gov

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NCT04792684

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