Cell Free DNA Blood Test for Colorectal Cancer

Overseen By Jane Samaniego, MS, PMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Colorectal cancer, Surgery, Family history, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new blood test, called cell-free DNA (cfDNA), can increase screening frequency for colorectal cancer, particularly in high-risk groups. Participants will be divided into two groups: one will receive standard screening options like at-home stool tests or colonoscopies, while the other will have these options plus the new cfDNA blood test. The trial seeks individuals who haven't recently undergone colorectal cancer screening and are attending primary care visits. Results could inform whether this blood test should become a regular screening method. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance cancer screening methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the cell free DNA blood test is safe for colorectal cancer screening?

Research has shown that the cell-free DNA (cfDNA) blood test is FDA-approved for screening colorectal cancer, indicating its safety for use in the United States. Studies have demonstrated that this test is 83% effective at detecting colorectal cancer (sensitivity) and 90% effective at avoiding false positives (specificity).

These studies have reported no serious side effects, suggesting that patients generally tolerate the test well. However, the test is less effective at detecting early-stage cancers and precancerous conditions. While this does not impact its safety, it is an important consideration for its effectiveness. Overall, evidence suggests that the cfDNA blood test is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cell free DNA (cfDNA) blood test for colorectal cancer screening because it offers a unique, non-invasive option compared to traditional methods like colonoscopies and at-home fecal immunochemical tests (FIT). Unlike these standard procedures, the cfDNA blood test can detect cancer-related genetic material circulating in the blood, potentially identifying cancer earlier and more accurately. This method could simplify the screening process, making it more accessible and less uncomfortable for patients, which might improve participation rates in colorectal cancer screening.

What evidence suggests that the cfDNA blood test is effective for colorectal cancer screening?

Research has shown that blood tests for cell-free DNA (cfDNA) can help detect colorectal cancer (CRC). These tests identify unusual DNA fragments in the blood, often originating from cancer cells. Previous studies found that cfDNA tests effectively detect cancer when present. Additionally, cfDNA tests are non-invasive, requiring no surgery or other procedures, which might encourage more people to undergo screening. In this trial, participants in the intervention group will have the option to use the cfDNA blood test alongside other screening methods. While this test appears promising, further research is needed to confirm its effectiveness, especially across diverse populations.

Who Is on the Research Team?

Job G Godino, PhD

Principal Investigator

Family Health Centers of San Diego

Samir Gupta, MD, MSCS, AGAF

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for individuals eligible for colorectal cancer screening who are not currently up-to-date with their screenings. It's focused on patients from a Federally Qualified Health Center, which often serves those at higher risk for inequities in health outcomes.

Inclusion Criteria

Not up-to-date with screening, defined based on an existing electronic health record (EHR)-based flag that indicates absence of FIT within the last 12 months, colonoscopy within the last 10 years, sigmoidoscopy within the last 5 years, or multi-target stool DNA (Cologuard) test within 3 years

Attending primary care visits during the 2 months of recruitment. Screening status will be confirmed by primary care providers as part of routine visits

Being provided the informed consent form

Exclusion Criteria

Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years

I have a history of colorectal cancer or related conditions.

I have had surgery for colorectal cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to either usual care or expanded screening options, including at home FIT, colonoscopy, or cfDNA blood test

8 weeks

1 visit (in-person) for cfDNA blood test, at home FIT completion

Follow-up

Participants are monitored for screening completion and outcomes within 60 days of enrollment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cell free DNA (cfDNA) blood test

Trial Overview The study compares standard colorectal cancer screening methods (at-home fecal test or colonoscopy) to an expanded option that includes the new cfDNA blood test plus the at-home fecal test. Participants will be randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 2 Interventions

Participants randomized to the intervention group will be offered expanded colorectal cancer screening options: at home FIT, colonoscopy, or additional option of an in clinic FDA-approved cfDNA blood test with at home FIT.

Group II: Usual Care Group Active Control 1 Intervention

Participants randomized to the usual care group will be offered standard colorectal cancer screening options: at home FIT or colonoscopy.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

CUREBOUND, INC.

Collaborator

Family Health Centers of San Diego

Collaborator

Trials

9

Recruited

15,000+

Citations

1. academic.oup.com academic.oup.com/jnci/advance-article/doi/10.1093/jnci/djaf277/8272727

Comparative benefits, burdens, and harms of emerging blood ... Emerging blood tests may improve colorectal cancer (CRC) screening uptake and outcomes but are less sensitive for advanced precancerous ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06929481

Screening With a DNA Blood Test to Address Colorectal ... The intervention is a novel blood test that evaluates circulating cell free tumor DNA (cfDNA) and detects colorectal cancer (CRC). Recently, the cfDNA test has ...

3. shieldcancerscreen.com shieldcancerscreen.com/

Shield™ by Guardant Health | Official Site Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38477985/

A Cell-free DNA Blood-Based Test for Colorectal Cancer ... Conclusions: In an average-risk screening population, this cfDNA blood-based test had 83% sensitivity for colorectal cancer, 90% specificity for ...

5. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=299

Screening for Colorectal Cancer - Blood-Based Biomarker ... Currently, this test is the only FDA approved commercially available blood-based CRC screening test that is marketed in the US. As with other noninvasive fecal ...