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

NCT06119425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

  • Cancer Colon

Interventions

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.

Sponsors & Collaborators

  • Guardant Health, Inc.

    collaborator INDUSTRY

  • Ballad Health

    lead OTHER

Principal Investigators

  • Karen J. Elmore, MD · Ballad Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119425 on ClinicalTrials.gov