Status:
ENROLLING_BY_INVITATION
Screening With a DNA Blood Test to Address Colorectal Cancer Inequities
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
CUREBOUND, INC.
Family Health Centers of San Diego
Conditions:
Colorectal Cancer Screening
Colorectal Cancer (CRC)
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief 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...
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, includi...
Eligibility Criteria
Inclusion
- Persons, aged 45 to 75 years old
- 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. According to routine practice, screening status will be confirmed by primary care providers as part of routine visits.
- Being provided the informed consent form.
Exclusion
- Personal history of colorectal cancer (CRC), adenomas, or other related cancers.
- Prior history of colorectal surgery
- Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age.
- 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
- Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years.
- 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
- 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.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06929481
Start Date
April 28 2025
End Date
May 1 2026
Last Update
May 2 2025
Active Locations (1)
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1
Family Health Centers of San Diego, Logan Heights site
San Diego, California, United States, 92113