Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

May 24, 2026 updated by: Samir Gupta, University of California, San Diego

Screening With Liquid Biopsies to Address Colorectal Cancer Inequities

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients assigned to usual care will be offered options for screening using a standardized script outlining: 1) importance of screening; 2) option of screening with at home FIT or colonoscopy, including key characteristics. Description of key characteristics will include 1) test completion steps; 2) test performance, stating that colonoscopy picks up 9 out of 10 colorectal cancers and important growths called polyps, and that FIT picks up 3 in 4 cancers and 1 in 4 important polyps (we define "important polyps" as adenomas 1 centimeter or larger in size or containing villous/tubulovillous histology or high-grade dysplasia). The script will note abnormal FIT requires a colonoscopy to check for CRC and important growths. Patients assigned to the intervention group will receive an identical offer, but with additional option of screening with an in clinic cfDNA plus an at home FIT. The script will state cfDNA is a blood test meant to be complementary to current screening with ability to detect 8 out of 10 CRCs and 1 in 10 important polyps, and offers advantage of having a same day test for CRC detection to complement the FIT that they will do at home. The script will also state colonoscopy is required if either cfDNA or FIT is abnormal. For patients who opt for the cfDNA plus at home FIT option, the study team will coordinate same day blood draw. Following manufacturer's instructions, 40 mL of blood (4 tubes each with 10 mL of blood) will be collected and sent to Guardant Health for the Guardant Shield test. Patients will be instructed to complete the FIT as soon as possible and within 5 days, and, to minimize the influence of cfDNA result on likelihood of FIT completion, cfDNA results will not be disclosed to the patient for 14 days after the clinic visit. For all subjects, demographic characteristics, coded data on primary provider of record, and outcomes will be collected. Because this is planned as a pragmatic trial to mimic the potential impact of introducing the cfDNA test into usual care, and because the study poses minimum risk and promotes potentially lifesaving colorectal cancer screening, a waiver of informed consent for study screening and randomization to study group assignment, and for written documentation of informed consent has been approved. An informed consent sheet with the option to "opt out" of the study will be provided to all potential subjects.

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92113
        • Family Health Centers of San Diego, Logan Heights site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Persons, aged 45 to 75 years old
  2. 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.
  3. Attending primary care visits during the 2 months of recruitment. According to routine practice, screening status will be confirmed by primary care providers as part of routine visits.
  4. Being provided the informed consent form.

Exclusion Criteria:

  1. Personal history of colorectal cancer (CRC), adenomas, or other related cancers.
  2. Prior history of colorectal surgery
  3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age.

  4. Up-to-date with colorectal cancer screening, defined as:

    • Fecal occult blood test (FOBT) or FIT within the last 12 months
    • FIT-DNA (Cologuard) or FIT-RNA (Colosense) test within 3 years
    • cfDNA (Shield) within the last year
    • CT colonography within the last 5 years
    • Sigmoidoscopy within the last 5 years
    • Colonoscopy within the last 10 years
  5. Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years.

  6. Personal history of any of the following high-risk conditions for colorectal cancer:

    • Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease
    • Familial adenomatous polyposis (FAP)

    • Other hereditary cancer syndromes including but not limited to:

      • Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz-Jeghers Syndrome, MUTYH Polyposis (MAP), Familial Adenomatous Polyposis (FAP), Cowden's Syndrome, Juvenile Polyposis, Serrated Polyposis Syndrome
  7. Uninsured patients will be excluded because of inability to ensure follow up. Because of recently expanded Medi-Cal eligibility, exclusions due to insurance are expected to be minimal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
Device: Cell free DNA (cfDNA) blood test
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 been shown to have 83% sensitivity and 90% specificity for CRC detection, and 13% sensitivity for advanced polyp detection, heralding a new screening strategy postulated to be highly convenient and acceptable. The cfDNA test is made by Guardant Health, FDA approved for average risk colorectal cancer screening, and marketed with the brand name "Shield". Patients opting for the cfDNA test will also be requested to complete an at home FIT.
Other Names:
  • cfDNA
  • cfDNA blood test
  • Guardant Shield cfDNA test
  • Guardant Shield test
Other: At home Fecal Immunochemical Test (FIT) or Colonoscopy
The usual care group will be offered standard colorectal cancer screening options to choose from: at home FIT or colonoscopy.
Other Names:
  • at home FIT or colonoscopy
Active Comparator: Usual Care Group
Participants randomized to the usual care group will be offered standard colorectal cancer screening options: at home FIT or colonoscopy.
Other: At home Fecal Immunochemical Test (FIT) or Colonoscopy
The usual care group will be offered standard colorectal cancer screening options to choose from: at home FIT or colonoscopy.
Other Names:
  • at home FIT or colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screening completion
Time Frame: 60 Days
A single primary outcome measure, screening completion within 60 days of enrollment, is planned. The outcome measure will be defined as the proportion of people enrolled who complete a colorectal cancer screening test within 60 days of enrollment. The definition of colorectal cancer screening test completion includes exposure to a fecal immunochemical test, colonoscopy, or cell free DNA test. The outcome measure will be computed for the standard versus expanded option groups, and compared via a chi-squared test of proportions.
60 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Family Health Centers of San Diego
CUREBOUND, INC.

Investigators

  • Principal Investigator: Samir Gupta, MD, MSCS, AGAF, University of California, San Diego
  • Principal Investigator: Job G Godino, PhD, Family Health Centers of San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 811489
  • 316051-00001 (Other Grant/Funding Number: CUREBOUND, INC.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The trial results will be submitted for peer review publication. A limited, de-identified dataset for replication of analyses will be made available upon request to the corresponding author, and with execution of a data use agreement, if permitted by the human subjects protection programs at UCSD and FHCSD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Cancer Screening

Clinical Trials on Cell free DNA (cfDNA) blood test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe