Head to Head Trial of Mailed Cologuard to Mailed FIT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cologuard, Fecal Immunochemical Test.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Screening, Fecal Immunochemical Test, Multi-target Stool DNA, Colorectal Cancer (CRC). Basic parameters: 45 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
Overview
The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (Cologuard) and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.
Detailed description
Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of Cologuard or FIT positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and CRC incidence, measured within 24 months of randomization.
Interventions
- Diagnostic test Cologuard
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer. - Diagnostic test Fecal Immunochemical Test
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
Primary outcome measures
- Proportion of Colorectal cancer screening completion [Time frame: Within 12 months of randomization]
Secondary outcome measures (3)
- Proportion of Abnormal stool blood test results [Time frame: Within 12 months of randomization]
- Proportion of Follow-up colonoscopy after abnormal stool blood test result [Time frame: Within 24 months after randomization]
- Colorectal cancer incidence [Time frame: Within 24 months after randomization]
Eligibility criteria
Inclusion criteria
- Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health
- ≥1 UCSD Health System health visit within the last year
- Resides in San Diego or Imperial County
- Currently not up to date with CRC screening
- Insured by private, public or other health insurance.
Exclusion criteria
- Up-to-date with screening
- Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer.
- Prior history of colectomy
- Lack of health insurance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- University of California San Diego — La Jolla
Identifiers
NCT: NCT06931860 · 80312400 · R00CA267181 · 4R00CA267181-03