Trial results for a pilot study investigating mailed outreach of Cologuard versus the fecal immunochemical test (FIT) for Colorectal Cancer screening were posted on ClinicalTrials.gov on 2026-05-12. The study found that 5 participants completed colorectal cancer screening through mailed Cologuard outreach, compared to 3 participants through mailed FIT outreach.
Background
Colorectal cancer remains a significant public health concern, and early detection through screening is crucial for improving outcomes. Non-invasive stool-based tests, such as Cologuard and the fecal immunochemical test (FIT), offer convenient screening options that can be performed at home. Mailed outreach programs aim to increase screening rates by directly providing these tests to eligible individuals. This pilot study sought to compare the effectiveness of mailed Cologuard outreach against mailed FIT outreach in encouraging screening among eligible adults aged 45-49.
Trial design
This completed pilot study, identified as Phase NA, enrolled 12 participants with Colorectal Cancer. The objective was to compare the effectiveness of mailed outreach for two stool-based tests, Cologuard and FIT, in screening eligible adults aged 45-49 receiving care at the University of California San Diego Health system. Participants were assigned to either mailed Cologuard outreach or mailed FIT outreach.
Key results
The trial results provide insights into screening completion rates, abnormal test results, follow-up colonoscopies, and adenoma detection:
- For the outcome “Number of Participants Completing Colorectal Cancer Screening,” the Mailed Cologuard Outreach group had 5 Participants, while the Mailed Fecal Immunochemical Test Outreach group had 3 Participants.
- Regarding “Number of Participants With Abnormal Stool Blood Test Results,” the Mailed Cologuard Outreach group had 0 Participants, and the Mailed Fecal Immunochemical Test Outreach group had 1 Participant.
- For “Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result,” the Mailed Cologuard Outreach group had 0 Participants, and the Mailed Fecal Immunochemical Test Outreach group had 1 Participant.
- The “Number of Participants With Assigned Screening Test Successfully Ordered” was 6 Participants for the Mailed Cologuard Outreach group and 6 Participants for the Mailed Fecal Immunochemical Test Outreach group.
- The “Number of Participants Opting Out of the Pilot” was 0 Participants for both the Mailed Cologuard Outreach group and the Mailed Fecal Immunochemical Test Outreach group.
- For “Number of Adenomas Detected,” both the Mailed Cologuard Outreach group and the Mailed Fecal Immunochemical Test Outreach group had 1 Participant.
What this means
The results of this pilot study suggest that mailed outreach can successfully engage participants in colorectal cancer screening. In this small sample, mailed Cologuard outreach led to a higher number of completed screenings (5 participants) compared to mailed FIT outreach (3 participants), despite both groups having 6 assigned screening tests successfully ordered. One participant in the FIT group had an abnormal stool blood test result, which led to a follow-up colonoscopy and the detection of an adenoma. Notably, an adenoma was also detected in one participant from the Cologuard group, even though no abnormal stool blood test result was reported for that group. These findings provide preliminary data on the comparative effectiveness of different mailed screening outreach strategies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06173375, titled “Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT,” were posted on 2026-05-12 on clinicaltrials.gov.