Colon Cancer
Conditions
Keywords
Colon Cancer Screening
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.
Interventions
DIAGNOSTIC_TESTGuardantSHIELD 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
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Colorectal Cancer Screening Completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Percentage of Participants Who Completed Follow-up Testing. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Guardant Shield Blood Test Patients will have the Guardant Shield blood test for colorectal cancer screening.
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 | 1,001 |
| Standard of Care Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening | 1,003 |
| Total | 2,004 |
Baseline characteristics
| Characteristic | Guardant Shield Blood Test | Standard of Care | Total |
|---|---|---|---|
| Age, Customized 45-49 | 29 Participants | 28 Participants | 57 Participants |
| Age, Customized 50-64 | 718 Participants | 722 Participants | 1440 Participants |
| Age, Customized 65-75 | 254 Participants | 253 Participants | 507 Participants |
| Prior CRC Screening No Prior CRC Screening | 480 Participants | 483 Participants | 963 Participants |
| Prior CRC Screening Prior CRC Screening | 521 Participants | 520 Participants | 1041 Participants |
| Race/Ethnicity, Customized Asian | 45 Participants | 31 Participants | 76 Participants |
| Race/Ethnicity, Customized Black | 60 Participants | 55 Participants | 115 Participants |
| Race/Ethnicity, Customized Hispanic(any race) | 31 Participants | 35 Participants | 66 Participants |
| Race/Ethnicity, Customized Other/Multiple/Unknown | 73 Participants | 73 Participants | 146 Participants |
| Race/Ethnicity, Customized White | 792 Participants | 809 Participants | 1601 Participants |
| Sex: Female, Male Female | 642 Participants | 598 Participants | 1240 Participants |
| Sex: Female, Male Male | 359 Participants | 405 Participants | 764 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,001 | 0 / 1,003 |
| other Total, other adverse events | 1 / 1,001 | 0 / 1,003 |
| serious Total, serious adverse events | 0 / 1,001 | 0 / 1,003 |
Outcome results
Primary
Assess Colorectal Cancer Screening Completion
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.
Time frame: Within 3 months of patient identification
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guardant Shield Blood Test | Assess Colorectal Cancer Screening Completion | 305 Participants |
| Standard of Care | Assess Colorectal Cancer Screening Completion | 130 Participants |
Secondary
Assess the Percentage of Participants Who Completed Follow-up Testing.
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.
Time frame: Within 6 months of abnormal FIT test
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Guardant Shield Blood Test | Assess the Percentage of Participants Who Completed Follow-up Testing. | 11 Participants |
| Standard of Care | Assess the Percentage of Participants Who Completed Follow-up Testing. | 7 Participants |