Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT
NCT ID: NCT06173375
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-05-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Cologuard
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
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.
Fecal Immunochemical Test
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
Interventions
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Cologuard
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 Test
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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.
Exclusion Criteria
* 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
45 Years
49 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Joshua Demb, PhD, MPH
Postdoctoral Scholar
Principal Investigators
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Joshua Demb, PhD
Role: PRINCIPAL_INVESTIGATOR
Postdoctoral Researcher
Locations
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University of California San Diego
La Jolla, California, United States
Countries
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Other Identifiers
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803124
Identifier Type: -
Identifier Source: org_study_id
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