Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 10:40 AM
Study NCT ID:
NCT06931860
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-09
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head to Head Trial of Mailed Cologuard to Mailed FIT
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R00CA267181 | NIH | None | https://reporter.nih.gov/quic… | View |
| 4R00CA267181-03 | NIH | None | https://reporter.nih.gov/quic… | View |