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NCT04792684RecruitingAccepts Healthy Volunteers

Collection of Samples USOPTIVAL Study

Universal Diagnostics

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

Inclusion Criteria: Arm A: 1. Must be 45-84 years of age. 2. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery. 3. Able to comprehend, sign, and date the written informed consent document. Arm B: 1. Must be 45-84 years of age. 2. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days. 3. Able to comprehend, sign, and date the written informed consent document. Exclusion Criteria: Arm A Only: 1\. Subject with curative biopsy during colonoscopy. Arm B Only: 1. Subjects with positive FIT Test results in the 6 months preceding enrollment. 2. Subject has a current diagnosis of cancer. Arms A \& B: 1. Subject has a personal history of aerodigestive or digestive tract cancers. 2. Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer. 3. Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer: 1. Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. 2. Familial adenomatous polyposis ("FAP", including attenuated FAP). 3. Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome"). 4. Serrated polyposis syndrome 5. 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer. 6. One first-degree relative with CRC diagnosed before the age of 60. 4. A significant disease which, in the Investigator's opinion, would exclude the subject from the study. 5. Legal incapacity or limited mental capacity. 6. Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent. 7. The patient has a known or documented previous or current medical history of infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.), including patients that have been treated, are currently being treated, or have not been treated for that conditions. 8. The patient is known to be pregnant when recruited or during her participation in the study.

Interventions

DIAGNOSTIC_TEST

Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Colorectal Cancer (CRC)Advanced Adenomas (AA)

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