Trials / Enrolling By Invitation
Enrolling By InvitationNCT06931860
Head to Head Trial of Mailed Cologuard to Mailed FIT
Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (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 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.
Conditions
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
- 2025-09-05
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2025-04-17
- Last updated
- 2025-09-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06931860. Inclusion in this directory is not an endorsement.