Study of Colorectal Cancer Screening Options
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Guardant Shield Blood Test Patients will have the Guardant Shield blood test for colorectal cancer screening. |
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
|
| No Intervention: Standard of Care Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening |
Outcome Measures
Primary Outcome Measures
- Assess colorectal cancer screening completion [Within 3 months of patient identification]
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.
Secondary Outcome Measures
- Assess the proportion who completed follow-up testing. [Within 6 months of abnormal FIT test]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 45-75
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Received a FIT test in the last 3-9 months yet did not return their FIT
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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:
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On KPNW's do not contact list
-
Having a legal authorized representative
-
Non-English speakers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Northwest | Portland | Oregon | United States | 97227 |
Sponsors and Collaborators
- Kaiser Permanente
Investigators
- Principal Investigator: Gloria Coronado, PhD, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KPNW Guardant [1866832-1]