Observational Study for Colorectal Cancer and Advanced Adenomas

This observational study, called USOPTIVAL, is collecting blood samples and health information from people to help improve a diagnostic test. The test, called Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel, looks for signs of colorectal cancer (CRC) and advanced adenomas (AA), which are growths that can become cancer. We are looking for people aged 45 to 84. You might be able to join if you have a suspected advanced adenoma or newly diagnosed CRC that hasn't been removed yet, or if you are scheduled for a routine colonoscopy. The main goal is to collect samples to test the cfDNA marker panel. The study is currently recruiting participants.

Study design
This is an observational study aiming to enroll 1300 participants. It is not a treatment study, but rather collects information and samples.
What's involved
If you join, you will provide up to 40 ml of blood at a study visit. You will also provide clinical data.
Compensation
Not stated in the trial record.
Follow-up
Samples will be collected for testing within 12 months of sample collection.

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

NCT04792684

Collection of Samples USOPTIVAL Study

Recruiting
Not specifiedAges 45–84Observational
Universal Diagnostics
~1,300 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel

At a glance

Recruiting sites
4 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing
Measured over Within 12 months of sample collection
Colorectal Cancer (CRC)
Advanced Adenomas (AA)
16 sites across 10 states
California4
Pennsylvania3
Florida2
Illinois1
Louisiana1
Massachusetts1
New York1
Tennessee1

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  • Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker TestingWithin 12 months of sample collection

    Samples Collected for Testing