Study of Colorectal Cancer Screening Options
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Guardant Shield Blood Test
Patients will have the Guardant Shield blood test for colorectal cancer screening.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess Colorectal Cancer Screening Completion
Time Frame: Within 3 months of patient identification
|
Assess the percentage 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 Percentage of Participants Who Completed Follow-up Testing.
Time Frame: Within 6 months of abnormal FIT test
|
Assess the percentage of participants 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gloria Coronado, PhD, Kaiser Permanente
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KPNW Guardant [1866832-1]
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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