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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cologuard | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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 | 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. | Within 3 months of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Opting Out of the Pilot | Measurement of feasibility of pilot to retain participants for the duration of study follow-up | Within 3 months of randomization |
| Number of Adenomas Detected |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who do Not Consent to Participate | Measurement of opt-in strategy prior to randomization to determine feasibility of recruitment strategy | Within one month of invitation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Demb, PhD | Postdoctoral Researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92126 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | Within 3 months of randomization |
|
From enrollment until end of follow-up, approximately one year
Adverse events for this pilot trial were documented via direct contact with consented individuals and manual abstraction of findings from electronic health records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This pilot study enrolled a small number of participants relative to those recruited. The requirement for informed consent and HIPAA authorization may have affected recruitment. The limited sample size restricts the ability to draw definitive conclusions and may impact generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Demb | University of California San Diego | (858) 822-3747 | jdemb@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2024 | Feb 24, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2024 | Feb 24, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)
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| Fecal Immunochemical Test | Diagnostic Test | Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer. |
|
|
Number of participants with adenomas detected during study period
| Within 6 months after screening test completion |
| Number of Sessile Serrated Lesions Detected | Number of participants with sessile serrated lesions detected during study period | 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 | 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. | Within 3 months of randomization |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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.
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Within 3 months of randomization |
|
|
|
| Primary | 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 | 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. | Posted | Count of Participants | Participants | Within 6 months after stool blood test completion |
|
|
|
| Primary | 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. | Characterize any instances where a participant was recruited, but the test was not successfully ordered. | Posted | Count of Participants | Participants | Within 3 months of randomization |
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| Secondary | Number of Participants Opting Out of the Pilot | Measurement of feasibility of pilot to retain participants for the duration of study follow-up | Posted | Count of Participants | Participants | Within 3 months of randomization |
|
|
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| Secondary | Number of Adenomas Detected | Number of participants with adenomas detected during study period | Only 2 participants in each arm had colonoscopies during study follow-up. | Posted | Count of Participants | Participants | Within 6 months after screening test completion |
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|
| Secondary | Number of Sessile Serrated Lesions Detected | Number of participants with sessile serrated lesions detected during study period | Only two individuals in both the mailed Cologuard and FIT arms completed colonoscopies during study follow-up. | Posted | Count of Participants | Participants | Within 6 months after screening test completion |
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| Secondary | Number of Participants With Colorectal Cancer Detected | Number of participants diagnosed with colorectal cancer during the study period | Posted | Count of Participants | Participants | Within 6 months after screening test completion |
|
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| Other Pre-specified | Number of Participants Who do Not Consent to Participate | Measurement of opt-in strategy prior to randomization to determine feasibility of recruitment strategy | Posted | Count of Participants | Participants | Within one month of invitation |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Within 3 months of randomization |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |