Head to Head Mailed Cologuard to Mailed FIT

Colorectal Cancer Clinical Trial

Official title:

Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173375
• Other study ID #: 803124
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: University of California, San Diego
• Contact: Joshua Demb, PhD, MPH
• Phone: 2406202774
• Email: jdemb[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Within 3 months of randomization
Primary	Proportion of Abnormal stool blood test results	Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.	Within 3 months of randomization
Primary	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	Within 6 months after stool blood test completion
Secondary	Number of participants opting out of the pilot	Measurement of feasibility of pilot	Within 3 months of randomization
Secondary	Number of participants with undeliverable FIT or Cologuard tests (mail fail rate)	Measurement of feasibility of mailed outreach	Within 3 months of randomization
Secondary	Number of Adenomas detected	Measurement of number of adenomas detected during study period	Within 6 months after screening test completion
Secondary	Number of sessile serrated lesions detected	Measurement of number of sessile serrated lesions detected during study period	Within 6 months after screening test completion
Secondary	Number of colorectal cancer cases detected	Number of colorectal cancers detected during study period	Within 6 months after screening test completion