NCT06119425

Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice Highlands

Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice in the Outpatient Clinical Settings in the Appalachian Highlands

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: Ballad Health · Academic / Other
• Sex: All
• Age: 45 Years – 84 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer Colon

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood-based CRC screening	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.

Timeline

• Start date: 2023-10-12
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-11-07
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study