Clinical trial · Interventional
Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT
Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach
NCT06173375CI-TRIAL-00111190completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cologuard | Diagnostic Test | — | UNRESOLVED |
| Fecal Immunochemical Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mailed Cologuard Outreach
- description
- Receipt of mailed Cologuard test for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 3 years. If test is positive, participant will be advised to schedule colonoscopy for further testing.
- interventionNames
- Diagnostic Test: Cologuard
- type
- ACTIVE_COMPARATOR
- label
- Mailed Fecal immunochemical test Outreach
- description
- Receipt of mailed FIT for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 1 year. If test is positive, participant will be advised to schedule colonoscopy for further testing.
- interventionNames
- Diagnostic Test: Fecal Immunochemical Test
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.