Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new blood test that looks for DNA from cancer cells to see if it can help more people get screened for colorectal cancer (CRC). Colorectal cancer screening is important, but many people, especially from certain racial or economic backgrounds, do not get screened as often as they should. The trial will compare two groups: one will be offered standard screening methods like at-home tests or colonoscopy, while the other will have the added option of the new blood test along with those standard methods. The goal is to find out if this new test can encourage more people to participate in screening and ultimately help detect cancer earlier.

To be eligible for this trial, participants need to be between 45 and 75 years old and not up-to-date with their CRC screenings. This means they haven’t had the necessary tests done within certain time frames. Participants will be recruited during their regular doctor visits, and their screening status will be checked. It’s important to note that people with a personal history of colorectal cancer, certain high-risk conditions, or who are already up-to-date on their screenings won't be able to participate. This trial aims to provide valuable information that could change guidelines for CRC screening in the future.

Gender

ALL

Eligibility criteria

• 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.