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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guardant Shield Blood Test | Other | Patients will have the Guardant Shield blood test for colorectal cancer screening. |
|
| Standard of Care | No Intervention | Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GuardantSHIELD Blood Test | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 3 months of patient identification |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 6 months of abnormal FIT test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Coronado, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38176899 | Derived | Coronado GD, Jenkins CL, Shuster E, Johnson C, Amy D, Cook J, Sahnow S, Zepp JM, Mummadi R. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024 Mar 7;73(4):622-628. doi: 10.1136/gutjnl-2023-330980. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard of Care | Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Within 3 months of patient identification |
|
9 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Patient had continued pain at site of the blood draw, the "puncture wound" would not stop hurting. Patient got care at an urgent care, no treatment necessary |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gloria D. Coronado, PhD - Professor, Associate Director Population Sciences, Cancer Center | University of Arizona | 520-626-0023 | gdcoronado@arizona.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 7, 2022 | Jun 6, 2024 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Standard of Care |
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Prior CRC Screening | Count of Participants | Participants |
|
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
|
|
| 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. | Posted | Count of Participants | Participants | Within 6 months of abnormal FIT test |
|
|
|
| 0 |
| 1,001 |
| 0 |
| 1,001 |
| 1 |
| 1,001 |
| EG001 | Standard of Care | Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening | 0 | 1,003 | 0 | 1,003 | 0 | 1,003 |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |