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| Name | Class |
|---|---|
| Guardant Health, Inc. | INDUSTRY |
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This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Study Rationale This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Although multiple screening options for CRC are available, participation and adherence to CRC screening remains below the national goal. CRC screening rate at the Ballad Health Mountain Laurel Internal Medicine clinic (site 1) is approximately 66%.
A blood-based test (BBT) can provide a clinically important complement to standard-of-care (SOC) screening tests and address unmet medical needs for patients, especially for those who are non-adherent with current screening modalities. There are economic and societal benefits in early detection and prevention of CRC in a broader population than the one currently up to date with screening. The unmet need for maximum participation in CRC screening could be addressed with blood-based testing.
Measuring subsequent provider experience and implementation behavior patterns involving blood based non-invasive cancer screening choices will also help to identify clinical utility of such test and implementation into clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening Discussion and Election | No Intervention | Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options. Patients who express a desire to be screened using the SOC options will be considered part of the control group. | |
| Screening Selection | Experimental | Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options as well as the option to be screened with a blood-based test which is not currently standard of care. Patients who express a desire to be screened using the SOC options or the blood-based non-SOC option will be considered part of the experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood-based CRC screening | Diagnostic Test | For this study, a commercially available blood-based CRC screening test will be used. The selected test is Shield (Guardant Health, Redwood City, California, USA). The Shield test was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, California, USA, which is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity clinical testing. The Shield test is currently commercially available as an laboratory developed test (LDT). Additionally, Guardant submitted the pre-market approval (PMA) application for the Shield test to the Food and Drug Administration (FDA) in March of 2023. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices. To this end, the Shield test is currently under review by the FDA. |
| Measure | Description | Time Frame |
|---|---|---|
| Opted to be screened for CRC by either SOC or study diagnostic test | Number of participants who agree to be screened CRC. % of participants who agree to be screened for CRC. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Opted to be screened by the study diagnostic test | Number of participants who opted to be screened by the study diagnostic test instead of | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen J. Elmore, MD | Ballad Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson City Medical Center | Johnson City | Tennessee | 37604 | United States |
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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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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |