NCT04792684 · Universal Diagnostics
Collection of Samples USOPTIVAL Study
What this study is about
A forward-looking 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Arm A Only: 1\. 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
- Chula Vista, California
- San Diego, California
- Walnut Creek, California
- Hollywood, Florida
- Lakeland, Florida
- Springfield, Illinois
- New Orleans, Louisiana
- Boston, Massachusetts
- New Windsor, New York
- Philadelphia, Pennsylvania
- Uniontown, Pennsylvania
- Union City, Tennessee
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations