Colorectal Cancer Clinical Trial
Official title:
Assessing the Effect of Offering a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion in Patients Who Have Refused Colonoscopy and FIT
Verified date | December 2022 |
Source | VA New York Harbor Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objectives: Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenient or unacceptable for a variety of reasons. There is an unmet need for a non-invasive test that does not require bowel preparation or handling stool, and the Septin9 DNA blood test may be an alternative for those individuals who would otherwise remain unscreened. Aims: Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical Center - Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test who undergo diagnostic colonoscopy - Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about colorectal cancer screening and testing options We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT will accept the blood test. We hypothesize this will be driven by the convenience of the blood test. Methods: This will be randomized controlled trial of individuals who have refused colonoscopy and FIT within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter and telephone call. The intervention group will also be invited to participate in the blood test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total n=360).
Status | Completed |
Enrollment | 359 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: - not up-to-date with colorectal cancer screening, defined as a colonoscopy in the past 10 years, a stool test (FOBT/FIT) in the past year, or a flexible sigmoidoscopy in the past 5 years. - Declined colorectal cancer screening (both colonoscopy and FIT) in the previous 6 months, which must be documented in the electronic health record Exclusion Criteria: - Personal history of colonic adenomas (including sessile serrated adenomas), proximal hyperplastic polyps, CRC, inflammatory bowel disease, or hereditary gastrointestinal cancer syndrome - First degree relative with CRC diagnosed at <60 years of age; family history of hereditary gastrointestinal cancer syndromes. - Vulnerable populations - Adult unable to consent - Individuals who are not yet adults (infants, children, teenagers) - Pregnant women - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | VA New York Harbor Health Care System | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Peter S. Liang, MD MPH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Who Undergo Screening Within 6 Months of Outreach | Percentage of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent | 6 months | |
Secondary | Percentage of Participants Completing Screening Strategy | Complete screening in both groups, which is defined as completion of the entire screening strategy. For colonoscopy, this requires cecal intubation and an adequate bowel preparation. For individuals who took Septin9 and FIT, positive results must be followed by a colonoscopy with cecal intubation and adequate bowel preparation. | 12 months | |
Secondary | Percentage of Participants With Colonoscopy Follow-up in Intervention Group | Among individuals in the intervention group who had a positive blood test, proportion who completed a follow-up colonoscopy within 6 months. | 6 months (after positive FIT) | |
Secondary | Self-reported Willingness to Take Blood Test for Colorectal Cancer Screening on Questionnaire | Percentage of both groups who answered that they would be willing to take a blood test for colorectal cancer screening | 1 day (assessed using baseline survey) | |
Secondary | Self-reported Most Common Advantages of Blood Test on Questionnaire | The most commonly cited advantages of a blood test compared to colonoscopy and stool test in both groups | 1 day (assessed using baseline survey) | |
Secondary | Self-reported Most Common Reasons for Refusing Blood Test on Questionnaire in Intervention Group | The most commonly cited reasons for not taking the blood test in the intervention group. | 1 day (assessed using baseline survey) |
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