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

340 Participants Needed

Trial Summary

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 data supports the effectiveness of the cell free DNA (cfDNA) blood test treatment for colorectal cancer?

Research shows that cell free DNA (cfDNA) can be a useful tool for diagnosing and monitoring colorectal cancer, as it helps in understanding the tumor's behavior and response to treatment. It is a promising method because it can be done with less cost and equipment compared to traditional methods. ^{1 2 3 4 5}

Is the cell-free DNA blood test safe for humans?

The cell-free DNA (cfDNA) blood test is considered safe as it is a minimally invasive procedure, meaning it involves only a simple blood draw without significant risk to participants. ^{2 3 6 7 8}

How is the cell-free DNA blood test treatment different from other treatments for colorectal cancer?

The cell-free DNA (cfDNA) blood test is unique because it analyzes DNA fragments in the blood to help detect and monitor colorectal cancer without needing prior knowledge of specific mutations, unlike traditional methods that often require tissue samples or known genetic profiles. ^{1 2 3 5 6}

What is the purpose of this trial?

Colorectal cancer (CRC) screening participation is suboptimal and associated with inequities in CRC outcomes by race/ethnicity and socioeconomic position. A novel, cell free DNA (cfDNA) blood test has potential to increase participation, but has not been studied in groups at highest risk for adverse CRC outcomes. Among patients age-eligible for colorectal cancer screening, not up-to-date, we propose a 2-arm, pragmatic, randomized controlled trial comparing offers of standard screening options (at home fecal immunochemical test (FIT) or colonoscopy) vs. offers of expanded options (at home FIT, colonoscopy, or in clinic cfDNA plus at home FIT), set at a large Federally Qualified Health Center serving individuals at increased risk for inequities in CRC outcomes. Results will inform guideline and policy makers on whether cfDNA should be supported as a screening option, and support planning for a large-scale trial examining impact of a cfDNA option for screening on CRC and advanced neoplasia detection.

Research Team

Samir Gupta, MD, MSCS, AGAF

Principal Investigator

University of California, San Diego

Job G Godino, PhD

Principal Investigator

Family Health Centers of San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Circulating cell-free DNA: a promising marker of pathologic tumor response in rectal cancer patients receiving preoperative chemoradiotherapy. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Methodological development and biological observations of cell free DNA with a simple direct fluorescent assay in colorectal cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Somatic copy number alteration and fragmentation analysis in circulating tumor DNA for cancer screening and treatment monitoring in colorectal cancer patients. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Cell-free circulating tumor DNA in colorectal cancer: a proof of concept with simplified methodology. [2022]

5. Egypt pubmed.ncbi.nlm.nih.gov

Plasma cfDNA for the Diagnosis and Prognosis of Colorectal Cancer. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Free circulating DNA as possible tumour marker in colorectal cancer. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Molecular Alterations in Circulating Cell-Free DNA in Patients with Colorectal Adenoma or Carcinoma. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Developing Quality Programs for Cell-Free DNA (cfDNA) Extraction from Peripheral Blood. [2023]