Collection of Samples USOPTIVAL Study

Recruiting now

Conditions studied: Colorectal Cancer (CRC), Advanced Adenomas (AA)

In brief

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.

Key facts

Study ID: NCT04792684
Run by: Universal Diagnostics
People needed: 1300
Starts: 2020-12-30
Expected to finish: 2025-12-30
Last updated by the study team: 2025-11-10

Who can join

Age: 45 and older, up to 84. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Arm A:
Must be 45-84 years of age.
Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery.
Able to comprehend, sign, and date the written informed consent document.
Arm B:
Must be 45-84 years of age.
Able and willing to undergo a standard-of-care screening colonoscopy within 60 days.
Able to comprehend, sign, and date the written informed consent document.

You may not qualify if…

Arm A Only:
Subject with curative biopsy during colonoscopy.
Arm B Only:
Subjects with positive FIT Test results in the 6 months preceding enrollment.
Subject has a current diagnosis of cancer.
Arms A \& B:
Subject has a personal history of aerodigestive or digestive tract cancers.
Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer.
Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer:
Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease.
Familial adenomatous polyposis ("FAP", including attenuated FAP).
Hereditary non-polyposis colorectal cancer syndrome ("HNPCC" or "Lynch Syndrome").
Serrated polyposis syndrome
2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer.
One first-degree relative with CRC diagnosed before the age of 60.
A significant disease which, in the Investigator's opinion, would exclude the subject from the study.
Legal incapacity or limited mental capacity.
Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent.
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.
The patient is known to be pregnant when recruited or during her participation in the study.

Where it is running

Springfield Clinic — Springfield, Illinois, United States (enrolling)
Mid Hudson Medical Research — New Windsor, New York, United States (enrolling)
University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Lakeland Regional Cancer Center — Lakeland, Florida, United States (enrolling)
Center for Gastrointestinal Disorders — Hollywood, Florida, United States
Ochsner Clinic — New Orleans, Louisiana, United States
Dana Farber Cancer Institute — Boston, Massachusetts, 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
Precision Recearch Institute — Chula Vista, California, United States
Gastroenterology Consultants of SW Virginia — Raonoke, Virginia, 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

Full record on ClinicalTrials.gov

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