Collecting blood samples to improve a blood test for early detection of colorectal cancer
Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (PROVE)
Researchers will test a blood-based DNA marker panel to see if it can detect colorectal cancer or advanced precancerous lesions in people with newly diagnosed, pre-treatment CRC and in average-risk adults having routine colonoscopies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6500 (estimated) |
| Ages | 45 Years to 84 Years |
| Sex | All |
| Sponsor | Universal Diagnostics Industry-sponsored |
| Locations | 1 site (Lake Barrington, Illinois) |
| Trial ID | NCT07310446 on ClinicalTrials.gov |
What this trial studies
This observational study will prospectively collect blood samples and clinical data from three groups: people newly diagnosed with colorectal cancer who are pre-treatment (including those scheduled for resection and those with histologic confirmation but not scheduled for surgery) and average-risk adults undergoing routine screening colonoscopy. The sponsor has identified circulating free DNA alterations—such as methylation patterns, fragmentation signatures, and copy-number changes—to form a preliminary marker panel. Samples from the US population will be used to optimize and finalize the panel and to characterize its performance for detecting CRC and advanced precancerous lesions. No investigational treatment is given; the protocol centers on specimen collection and clinical data linkage for assay development.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed, pre-treatment colorectal cancer or average-risk adults scheduled for routine colonoscopy who can give a blood sample and consent at the study site.
Not a fit: People already undergoing treatment for colorectal cancer or those with a prior history of CRC (for the screening arm) are unlikely to benefit from participation for the intended screening optimization.
Why it matters
Potential benefit: If successful, this work could lead to a simpler blood test that finds colorectal cancer or high-risk precancers earlier and could increase screening uptake.
How similar studies have performed: Other research into cfDNA methylation and fragmentation markers has shown promising but mixed results, with some tests demonstrating useful detection for certain cancers while widespread clinical adoption for CRC screening remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Arm A: Diagnosed with CRC * Arm B: Undergoing screening with colonoscopy for CRC Exclusion Criteria: * Arm A: Undergoing treatment for CRC, * Arm B: Past history of CRC
Where this trial is running
Lake Barrington, Illinois
- Gastroenterology and Internal Medicine Specialists — Lake Barrington, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Antonio Jesus Merino Calvo
- Email: antonio.merino@universaldx.com
- Phone: 674945571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.