Actively Recruiting
Collection of Samples USOPTIVAL Study
Led by Universal Diagnostics · Updated on 2025-11-10
1300
Participants Needed
16
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Collection of Samples USOPTIVAL Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 45 to 84 years old.
- For suspected advanced adenoma or newly diagnosed colorectal cancer (CRC) group: must be scheduled for resection surgery and not yet resected.
- For average-risk group: must be able and willing to have a standard screening colonoscopy within 60 days.
- Able to understand and sign the informed consent document.
You will not qualify if you...
- For suspected advanced adenoma or CRC group: subjects who had a curative biopsy during colonoscopy.
- For average-risk group: subjects with positive fecal immunochemical test (FIT) results within 6 months before enrollment.
- Subjects with a current diagnosis of cancer.
- Personal history of aerodigestive or digestive tract cancers.
- Previous partial colon surgery for reasons other than CRC.
- Diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's), familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (Lynch Syndrome), serrated polyposis syndrome.
- Two first-degree relatives diagnosed with colon cancer or one diagnosed before age 60.
- Significant disease that excludes participation.
- Legal incapacity or limited mental capacity.
- Medical or psychological conditions preventing study completion or informed consent.
- History of infectious diseases transmissible through blood (e.g., Hepatitis, HIV), treated or untreated.
- Known pregnancy at recruitment or during participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Precision Recearch Institute
Chula Vista, California, United States, 91910
Completed
2
Precision Research Institute
San Diego, California, United States, 92114
Completed
3
Medical Associates Research Group
San Diego, California, United States, 92123
Completed
4
Clinical Research of California
Walnut Creek, California, United States, 94598
Completed
5
Center for Gastrointestinal Disorders
Hollywood, Florida, United States, 33021
Completed
6
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Actively Recruiting
7
Springfield Clinic
Springfield, Illinois, United States, 62702
Actively Recruiting
8
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
Completed
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Completed
10
Mid Hudson Medical Research
New Windsor, New York, United States, 12553
Actively Recruiting
11
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Completed
13
Frontier Clinical Research
Uniontown, Pennsylvania, United States, 15401
Completed
14
Clinical Trials Network
Union City, Tennessee, United States, 38261
Completed
15
Vilo Research Group
Houston, Texas, United States, 77017
Completed
16
Gastroenterology Consultants of SW Virginia
Raonoke, Virginia, United States, 24014
Completed
Research Team
A
Antonio Jesus Merino Calvo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here