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Clinical Trials in the USA / NCT04792684
Recruiting Observational

Collection of Samples USOPTIVAL Study

NCT04792684 · tracked via the Priya Life Science USA tracker
Sponsor
Universal Diagnostics
Phase
Observational
Started
2020-12-30
Last updated
2025-11-10

Condition(s) studied

Colorectal Cancer (CRC)Advanced Adenomas (AA)

Investigational drug(s) / intervention(s)

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

Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel: Evaluate the performance of a preliminary panel of biomarkers

Study 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

Sex
ALL
Min age
45 Years
Max age
84 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Precision Recearch Institute Chula Vista California Completed
Precision Research Institute San Diego California Completed
Medical Associates Research Group San Diego California Completed
Clinical Research of California Walnut Creek California Completed
Center for Gastrointestinal Disorders Hollywood Florida Completed
Lakeland Regional Cancer Center Lakeland Florida Recruiting
Springfield Clinic Springfield Illinois Recruiting
Ochsner Clinic New Orleans Louisiana Completed
Dana Farber Cancer Institute Boston Massachusetts Completed
Mid Hudson Medical Research New Windsor New York Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Completed
Frontier Clinical Research Uniontown Pennsylvania Completed
Clinical Trials Network Union City Tennessee Completed
Vilo Research Group Houston Texas Completed
Gastroenterology Consultants of SW Virginia Raonoke Virginia Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04792684 on ClinicalTrials.gov ↗ ← All trials in the USA