Trial Outcomes & Findings for Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT (NCT NCT06173375)
NCT ID: NCT06173375
Last Updated: 2026-05-12
Results Overview
The number of participants who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Within 3 months of randomization
Results posted on
2026-05-12
Participant Flow
Recruitment occurred from May-Dec 2024 at UCSD Health primary care clinics. Eligible adults 45-49 were identified via EHR queries, mailed invitation letters, and follow-up calls.
A total of 200 individuals were identified as potentially eligible via EHR queries and invited to participate. Of these, 12 individuals provided informed consent and were randomized to study arms (6 to mailed Cologuard outreach and 6 to mailed FIT outreach). Only participants who consented and were randomized are included in the Participant Flow module.
Participant milestones
| Measure |
Mailed Cologuard Outreach
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.
|
Mailed Fecal Immunochemical Test Outreach
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT
Baseline characteristics by cohort
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 Years
n=1512 Participants
|
45.5 Years
n=504 Participants
|
45.5 Years
n=2016 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
8 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
4 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=1512 Participants
|
6 Participants
n=504 Participants
|
11 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=1512 Participants
|
3 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: Within 3 months of randomizationThe number of participants who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants Completing Colorectal Cancer Screening
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 3 months of randomizationAmong those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result.
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants With Abnormal Stool Blood Test Results
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 6 months after stool blood test completionPopulation: Only counting among individuals who had a positive stool blood test result. None of the Cologuard arm had this, but 1 individual in the mailed FIT arm had a positive result.
Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy
Outcome measures
| Measure |
Mailed Cologuard Outreach
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.
|
Mailed Fecal Immunochemical Test Outreach
n=1 Participants
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.
|
|---|---|---|
|
Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 3 months of randomizationPopulation: Characterize any instances where a participant was recruited, but the test was not successfully ordered.
Number of randomized participants for whom the assigned screening test order was successfully placed within the study period.
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants With Assigned Screening Test Successfully Ordered
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 3 months of randomizationMeasurement of feasibility of pilot to retain participants for the duration of study follow-up
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants Opting Out of the Pilot
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 6 months after screening test completionPopulation: Only 2 participants in each arm had colonoscopies during study follow-up.
Number of participants with adenomas detected during study period
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=2 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=2 Participants
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.
|
|---|---|---|
|
Number of Adenomas Detected
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 6 months after screening test completionPopulation: Only two individuals in both the mailed Cologuard and FIT arms completed colonoscopies during study follow-up.
Number of participants with sessile serrated lesions detected during study period
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=2 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=2 Participants
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.
|
|---|---|---|
|
Number of Sessile Serrated Lesions Detected
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 6 months after screening test completionNumber of participants diagnosed with colorectal cancer during the study period
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants With Colorectal Cancer Detected
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 months of randomizationThe number of participants who consented to participate who were intended to be mailed a FIT or Cologuard test, but the test was found to be undeliverable.
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=6 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within one month of invitationMeasurement of opt-in strategy prior to randomization to determine feasibility of recruitment strategy
Outcome measures
| Measure |
Mailed Cologuard Outreach
n=200 Participants
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.
|
Mailed Fecal Immunochemical Test Outreach
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.
|
|---|---|---|
|
Number of Participants Who do Not Consent to Participate
|
188 Participants
|
—
|
Adverse Events
Mailed Cologuard Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed Fecal Immunochemical Test Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place