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ENROLLING BY INVITATION

NCT06929481

Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

Summary

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.

Official title: Screening With Liquid Biopsies to Address Colorectal Cancer Inequities

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

340

Start Date

2025-04-28

Completion Date

2026-05

Last Updated

2025-05-02

Healthy Volunteers

Yes

Conditions

Colorectal Cancer Screening Colorectal Cancer (CRC)

Interventions

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

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.

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.

Locations (1)

Family Health Centers of San Diego, Logan Heights site

San Diego, California, United States