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Observational Study for Colorectal Cancer Blood Test Development

This study is collecting blood samples and health information from people to help develop a new blood test for colorectal cancer (CRC). Researchers are looking at changes in circulating free-DNA (cfDNA) in the blood to find markers that can detect CRC early. You might be able to join if you are between 45 and 84 years old and have been newly diagnosed with CRC, or if you are having a colonoscopy for CRC screening. The goal is to improve this blood test for use in the US population. The study plans to enroll about 6,500 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include about 6,500 participants.
What's involved
Participants will provide blood samples and clinical data. The study involves one visit at baseline.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, assay development, is measured at baseline, suggesting no long-term follow-up after initial participation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07310446

Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance

Recruiting
Not specifiedAges 45–84Observational
Universal Diagnostics
~6,500 participants
Updated 2025-12-30 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Development of assay
Measured over Baseline

Conditions

Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Antonio Jesus Merino Calvo
[email protected]
674945571
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Arm A: Diagnosed with CRC
Arm B: Undergoing screening with colonoscopy for CRC

Exclusion

Arm A: Undergoing treatment for CRC,
Arm B: Past history of CRC

What this trial measures

  • Development of assayBaseline

    The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL.