cfDNA Marker Panel for Colorectal Cancer

Recruiting at 3 trial locations

Overseen By Antonio Jesus Merino Calvo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Universal Diagnostics

Disqualifiers: Cancer, IBD, FAP, Lynch syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve a blood test using circulating free-DNA (cfDNA) to detect colorectal cancer (CRC) and advanced adenomas (pre-cancerous growths). Participants in Arm A should have a suspected advanced adenoma or a recent CRC diagnosis and be awaiting surgery. Arm B includes those at average risk for CRC who are scheduled for a screening colonoscopy. The trial refines a biomarker panel, potentially leading to easier and earlier detection of these conditions. As an unphased trial, participants contribute to groundbreaking research that could enhance early detection methods for colorectal cancer.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that this cfDNA marker panel is safe for CRC and advanced adenoma detection?

Research has shown that using plasma circulating free-DNA (cfDNA) as a marker is generally safe for patients. Studies have found that cfDNA can help detect colorectal cancer (CRC) and advanced adenomas without causing harm. This method is non-invasive, avoiding surgery or risky procedures.

Although specific data on side effects is not available in the studies, cfDNA testing resembles other blood tests, which patients usually tolerate well. Reports of major unwanted side effects related to cfDNA testing are absent.

Based on current research, cfDNA marker panels appear to be a safe option for those participating in studies for detecting CRC and advanced adenomas. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about optimizing the plasma circulating free-DNA (cfDNA) marker panel because it could revolutionize how we detect colorectal cancer (CRC). Unlike traditional methods like colonoscopy or stool tests that require physical samples or invasive procedures, this approach uses a simple blood test to identify cancer markers. This non-invasive method could make screening more accessible and less uncomfortable for patients, potentially leading to earlier detection and better outcomes. Additionally, the cfDNA marker panel might offer more precise information about cancer's presence and progression, which could improve personalized treatment plans.

What evidence suggests that this cfDNA marker panel is effective for CRC and advanced adenoma detection?

This trial will evaluate the optimization of a plasma circulating free-DNA (cfDNA) marker panel for detecting colorectal cancer (CRC) and advanced adenomas. Research has shown that cfDNA can accurately detect CRC, making it a strong option for non-invasive screening. One study discovered that cfDNA with cancer-specific patterns can effectively identify CRC. However, non-cancerous colon growths are less likely to release DNA into the blood, which might make them harder to detect. Overall, cfDNA offers a potential method for early CRC screening and diagnosis, but it might not be as effective for detecting non-cancerous growths. Participants in Arm A of this trial will include subjects with suspected advanced adenomas or newly diagnosed CRC, while Arm B will include subjects at average risk for CRC undergoing screening colonoscopy. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Blood samples and clinical data are collected from subjects for biomarker panel optimization and evaluation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after sample collection

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy

Group II: Arm A. Experimental Treatment 1 Intervention

Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery

Who Is Running the Clinical Trial?

Universal Diagnostics

Lead Sponsor

Trials

3

Recruited

16,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04792684

NCT04792684 | Collection of Samples USOPTIVAL 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 ...

2. oncotarget.com oncotarget.com/article/25314/text/

Circulating cell free DNA as the diagnostic marker for ... This study is the first meta-analysis to systematically evaluate the diagnostic accuracy of circulating cfDNA as non-invasive biomarkers for ...

3. molecular-cancer.biomedcentral.com molecular-cancer.biomedcentral.com/articles/10.1186/s12943-023-01866-z

Efficacy of cell-free DNA methylation-based blood test for ... We developed a noninvasive blood-based CRC test, ColonSecure, based on cell-free DNA containing cancer-specific CpG island methylation patterns.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11853481/

Application of plasma cell-free DNA in screening ... This review summarizes the progress in research on different biological characteristics of cfDNA and its utility in the screening of advanced colorectal ...

5. nature.com nature.com/articles/s41419-018-0934-x

Circulating tumor DNA in patients with colorectal adenomas We conclude that benign colon lesions display extensive genetic heterogeneity, that they are not prone to release DNA into the circulation and are unlikely to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8175143/

Plasma DNA Integrity as a Prognostic Biomarker for ... In this study, we observed decreased cfDNA integrity in therapy CRC compared to primary CRC, and cfDNA integrity was able to perform as a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0888754324000971

Early detection and stratification of colorectal cancer using ... This study aims to establish prediction models for detecting CRC using plasma cell-free DNA (cfDNA) fragmentomic features.

8. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02313-z

Application of plasma cell-free DNA in screening of advanced ... This review summarizes the progress in research on different biological characteristics of cfDNA and its utility in the screening of advanced colorectal ...

9. nature.com nature.com/articles/s41698-025-00876-y

Circulating tumor DNA to monitor treatment response in ... In this review, we provide a comprehensive, up-to-date summary of ctDNA in monitoring treatment response with a focus on lung, colorectal, and breast cancers.