NCT05987709

Study of Colorectal Cancer Screening Options

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,004 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

Detailed description

The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening. Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who are non-adherent after receiving stool test outreach, who have an upcoming clinical appointment, and who are offered a commercially available colorectal cancer blood test versus usual care (i.e. reminder to complete stool testing during their clinical appointment). Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the test (based on available test performance characteristics) and willingness to obtain/offer the test on an on-going basis, based on qualitative interviews; assess preliminary rates of follow-up colonoscopy completion (after an initial abnormal test result) among participants allocated to the blood test vs. usual care condition.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	GuardantSHIELD Blood Test	The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC

Timeline

• Start date: 2022-03-17
• Primary completion: 2022-12-31
• Completion: 2023-06-15
• First posted: 2023-08-14
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

1 site across 1 country: United States