Study of Colorectal Cancer Screening Options

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Colorectal Cancer Screening Options

Conditions
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Colon Cancer

Intervention / Treatment
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* Diagnostic Test: GuardantSHIELD Blood Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-75 Received a FIT test in the last 3-9 months yet did not return their FIT Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6 weeks Able and willing to provide informed consent if in the intervention arm Exclusion Criteria: On KPNW's do not contact list Having a legal authorized representative Non-English speakers

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Guardant Shield Blood Test<br>Patients will have the Guardant Shield blood test for colorectal cancer screening. | Diagnostic Test: GuardantSHIELD Blood Test<br>* 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<br>|
| No Intervention: Standard of Care<br>Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess colorectal cancer screening completion | Assess the proportion who received any CRC screening test (blood draw, FIT or FIT-DNA, or flexible sigmoidoscopy or colonoscopy) within 3 months of eligibility determination among eligible individuals in the blood test and usual care groups. | Within 3 months of patient identification | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the proportion who completed follow-up testing. | Assess the proportion who completed follow-up colonoscopy within 6 months of their result among individuals with an abnormal non-invasive test result; comparing the blood test and usual care groups. | Within 6 months of abnormal FIT test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon Cancer Screening