University of California San Diego
La Jolla, California, 92093, United States
NCT Number: NCT06931860
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.
Interested in participating?
Request Info45 year–49 year
All sexes
Interventional
Not applicable
La Jolla, California, 92093, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
Time frame: Within 12 months of randomization
The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Time frame: Within 12 months of randomization
Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.
Time frame: Within 24 months after randomization
Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy
Time frame: Within 24 months after randomization
Number of colorectal cancers detected during study period
University of California, San Diego
Other
Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06929481
Colonic Diseases, Colorectal Cancer (CRC)
San Diego, California, United States
View Trial DetailsNCT06741293
Colonic Diseases, Colorectal Cancer (CRC)
Lisbon, Lisbon District, Portugal
View Trial DetailsNCT06597955
Colonic Diseases, Colorectal Cancer Screening
Indianapolis, Indiana, United States
View Trial DetailsNCT06184594
Colonic Diseases, Colorectal Cancer Screening
New York, United States
View Trial Details