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")
1 other identifier
observational
1,300
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 10, 2025
November 1, 2025
5 years
March 8, 2021
November 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing
Samples Collected for Testing
Within 12 months of sample collection
Study Arms (2)
Arm A.
Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery
Arm B
Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy
Interventions
Evaluate the performance of a preliminary panel of biomarkers
Eligibility Criteria
Two cohorts of patients aged between 45 and 84, who have a suspected advanced adenoma or have been newly diagnosed with CRC, still not resected and scheduled for surgery, and patients who are at average risk of developing colorectal cancer, scheduled for a standard-of-care screening colonoscopy. Subjects will be considered enrolled after understanding and signing the ICF and a determination is made by the Investigator that the subject is eligible to participate according to the inclusion/exclusion criteria. Enrollment will be stopped when a sufficient number of confirmed cases of colorectal cancer, advanced adenomas, and matching control subjects have been enrolled. Under the current assumptions, 1,200 subjects will need to be enrolled.
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
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Biospecimen
40 ml of blood at the study visit processed for plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2021
First Posted
March 11, 2021
Study Start
December 30, 2020
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share