Colorectal Cancer ScreeningNCT06931860
Head to Head Trial of Mailed Cologuard to Mailed FIT
A study testing Cologuard and Fecal Immunochemical Test in people with Colorectal Cancer Screening and Fecal Immunochemical Test, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 49 years
- Conditions the study is for
- Colorectal Cancer Screening, Fecal Immunochemical Test, Multi-target Stool DNA
- What is being tested?
- Cologuard and Fecal Immunochemical Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Official title: Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
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.
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 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.
- Conditions
- Colorectal Cancer Screening, Fecal Immunochemical Test, Multi-target Stool DNA, Colorectal Cancer (CRC)
- Being tested
- Cologuard, Fecal Immunochemical Test
- Keywords
- screening, early detection, colorectal cancer, stool blood test, mailed outreach
- 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
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 | Experimental | 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.
Proportion of Colorectal cancer screening completion
The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Measured: Within 12 months of randomization
Secondary outcomes (3)
Proportion of Abnormal stool blood test results
Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.
Measured: Within 12 months of randomization
Proportion of Follow-up colonoscopy after abnormal stool blood test result
Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy
Measured: Within 24 months after randomization
Colorectal cancer incidence
Number of colorectal cancers detected during study period
Measured: Within 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start5 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- 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 1) to mailed FIT outreach (Intervention 2)
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Joshua Demb, PhD, MPH, University of California, San Diego
- Investigators
- Joshua Demb, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931860
- Sponsor's protocol ID
- 80312400
- Other IDs
- R00CA267181, 4R00CA267181-03
- Status last verified
- Sep 2025
- First submitted
- 9 Apr 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data being used for this project involves protected health information that requires special training and completion of research proposals, IRB applications and data use requests directly with University of California San Diego Health System to obtain access. Therefore, we do not anticipate creating unique data resources as part of this study. If researchers receive permission via IRB applications and data use requests to work with these data, we will make available individual-level scientific data used in our study. The rationale is based on restrictions put forth as part of our Institutional Review Board (IRB) protocol and the need to protect study participants from risks associated with their participation. Specifically, our study outlines that data access will be limited to study personnel and will only be accessible for those individuals who have IRB-required training with access to a secure HIPAA research server.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
- ClinicalTrials.gov ID
- NCT06931860
- Acronym / sponsor ID
- 80312400
- Conditions
- Colorectal Cancer Screening, Fecal Immunochemical Test, Multi-target Stool DNA, Colorectal Cancer (CRC)
- Keywords
- screening, early detection, colorectal cancer, stool blood test, mailed outreach
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
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 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 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 1) to mailed FIT outreach (Intervention 2)
| 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 | Experimental | 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 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
Proportion of Colorectal cancer screening completion
Time frame: Within 12 months of randomization
The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
3 secondary outcomes
Proportion of Abnormal stool blood test results
Time frame: Within 12 months of randomization
Proportion of Follow-up colonoscopy after abnormal stool blood test result
Time frame: Within 24 months after randomization
Colorectal cancer incidence
Time frame: Within 24 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No. Data being used for this project involves protected health information that requires special training and completion of research proposals, IRB applications and data use requests directly with University of California San Diego Health System to obtain access. Therefore, we do not anticipate creating unique data resources as part of this study. If researchers receive permission via IRB applications and data use requests to work with these data, we will make available individual-level scientific data used in our study. The rationale is based on restrictions put forth as part of our Institutional Review Board (IRB) protocol and the need to protect study participants from risks associated with their participation. Specifically, our study outlines that data access will be limited to study personnel and will only be accessible for those individuals who have IRB-required training with access to a secure HIPAA research server.
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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.
Joshua Demb, PhD, MPH principal investigator
University of California, San Diego
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 Screening and Fecal Immunochemical Test, 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of Colorectal cancer screening completion (time frame: Within 12 months of randomization). 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 9 Sep 2025.