NCT06173375

Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 45 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, 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 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-12-31
• Completion: 2025-12-01
• First posted: 2023-12-15
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study