Back to resultsStudy of Colorectal Cancer Screening Options
Primary Purpose
Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GuardantSHIELD Blood Test
Sponsored by
About this trial
This is an interventional screening trial for Colon Cancer focused on measuring Colon Cancer Screening
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente Northwest
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Guardant Shield Blood Test
Standard of Care
Arm Description
Patients will have the Guardant Shield blood test for colorectal cancer screening.
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05987709
Brief Title
Study of Colorectal Cancer Screening Options
Official Title
Study of Colorectal Cancer Screening Options
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colon Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guardant Shield Blood Test
Arm Type
Other
Arm Description
Patients will have the Guardant Shield blood test for colorectal cancer screening.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
Intervention Type
Diagnostic Test
Intervention Name(s)
GuardantSHIELD Blood Test
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess colorectal cancer screening completion
Description
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.
Time Frame
Within 3 months of patient identification
Secondary Outcome Measure Information:
Title
Assess the proportion who completed follow-up testing.
Description
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.
Time Frame
Within 6 months of abnormal FIT test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Coronado, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Colorectal Cancer Screening Options
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