Clinical trial Recruiting at 1 site Observational Ages 45 to 84

Collecting blood samples to improve a blood test for early detection of colorectal cancer

Official title: 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)

Run by Universal Diagnostics · NCT07310446 · Data updated 2026-11-12

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.

More Colorectal Cancer trials

Quick facts

Study typeObservational
Ages45 Years to 84 Years
SexAll
Enrollment6500 (estimated)
SponsorUniversal Diagnostics
Industry-sponsored
Locations1 site (Lake Barrington, Illinois)
StatusRecruiting
StartedJuly 31, 2023
Main results expectedDecember 31, 2026
Study endsJuly 2027
Registry record updatedDecember 30, 2025
Trial IDNCT07310446 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Gastroenterology and Internal Medicine Specialists
    Lake Barrington, Illinois, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.