Colorectal CancerNCT06173375
Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT
A study testing Cologuard and Fecal Immunochemical Test in people with Colorectal Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 49 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cologuard and Fecal Immunochemical Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92126
About this study
Official title: Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach
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.
Read the 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 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.
- Conditions
- Colorectal Cancer
- Being tested
- Cologuard, Fecal Immunochemical Test
- Keywords
- screening, early detection, stool blood test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CologuardDiagnostic test
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
Fecal Immunochemical TestDiagnostic test
Also called OC-Sensor Test
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Mailed Cologuard Outreach | Experimental | 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. Receives: Diagnostic Test: Cologuard |
| Mailed Fecal immunochemical test Outreach | Active comparator | 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. Receives: Diagnostic Test: Fecal Immunochemical Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing Colorectal Cancer Screening
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)
Measured: Within 3 months of randomization
Number of Participants With Abnormal Stool Blood Test Results
Among those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result.
Measured: Within 3 months of randomization
Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result
Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy
Measured: Within 6 months after stool blood test completion
Number of Participants With Assigned Screening Test Successfully Ordered
Number of randomized participants for whom the assigned screening test order was successfully placed within the study period.
Measured: Within 3 months of randomization
Secondary outcomes (5)
Number of Participants Opting Out of the Pilot
Measurement of feasibility of pilot to retain participants for the duration of study follow-up
Measured: Within 3 months of randomization
Number of Adenomas Detected
Number of participants with adenomas detected during study period
Measured: Within 6 months after screening test completion
Number of Sessile Serrated Lesions Detected
Number of participants with sessile serrated lesions detected during study period
Measured: Within 6 months after screening test completion
Number of Participants With Colorectal Cancer Detected
Number of participants diagnosed with colorectal cancer during the study period
Measured: Within 6 months after screening test completion
Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate)
The 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.
Measured: Within 3 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 May 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Demb, PhD, MPH, University of California, San Diego
- Investigators
- Joshua Demb, PhD, Principal investigator, Postdoctoral Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173375
- Sponsor's protocol ID
- 803124
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach
- ClinicalTrials.gov ID
- NCT06173375
- Acronym / sponsor ID
- 803124
- Conditions
- Colorectal Cancer
- Keywords
- screening, early detection, stool blood test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)
| Arm | Type | Receives |
|---|---|---|
| Mailed Cologuard Outreach | Experimental | Diagnostic Test: CologuardReceipt 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 | Active comparator | Diagnostic Test: Fecal Immunochemical TestReceipt 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. |
Who may qualify
- Ages
- 45 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CologuardMulti-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 | Mailed Cologuard Outreach |
| Fecal Immunochemical TestAlso: OC-Sensor TestStool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer. | Diagnostic test | Mailed Fecal immunochemical test Outreach |
Primary outcome
Number of Participants Completing Colorectal Cancer Screening
Time frame: Within 3 months of randomization
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)
Number of Participants With Abnormal Stool Blood Test Results
Time frame: Within 3 months of randomization
Among those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result.
Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result
Time frame: Within 6 months after stool blood test completion
Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy
Number of Participants With Assigned Screening Test Successfully Ordered
Time frame: Within 3 months of randomization
Number of randomized participants for whom the assigned screening test order was successfully placed within the study period.
5 secondary outcomes
Number of Participants Opting Out of the Pilot
Time frame: Within 3 months of randomization
Number of Adenomas Detected
Time frame: Within 6 months after screening test completion
Number of Sessile Serrated Lesions Detected
Time frame: Within 6 months after screening test completion
Number of Participants With Colorectal Cancer Detected
Time frame: Within 6 months after screening test completion
Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate)
Time frame: Within 3 months of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Demb, PhD principal investigator
Postdoctoral Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cologuard and Fecal Immunochemical Test in people with Colorectal Cancer, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Completing Colorectal Cancer Screening (time frame: Within 3 months of randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.