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

NCT06119425 | Completed FDA Device

• 1 other identifier: 2082244-1
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Opted to be screened by the study diagnostic test

  3 months

Study Arms (2)

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.

Diagnostic Test: blood-based CRC screening

Interventions

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.

Screening Selection

Eligibility Criteria

• Age: 45 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 45-84 years of age (inclusive)
• Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
• If a patient opts for blood-based test, they are able and willing to provide blood samples per protocol
• Ability to understand and the willingness to participate in the study

You may not qualify if:

• Patients with a personal history of CRC
• Patients with a known high-risk family history of CRC precluding the patient from being average risk
• Patients with known diagnosis of inflammatory bowel disease or history of polyps
• Patients who are currently symptomatic for CRC such as: blood in the stool
• Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
• Have a recorded up to date CRC screening
• Patients with a previous abnormal colonoscopy finding who are due for surveillance.

Sponsors & Collaborators

• Ballad Health: lead
• Guardant Health, Inc.: collaborator

Study Sites (1)

Johnson City Medical Center

Johnson City, Tennessee, 37604, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Karen J. Elmore, MD

  Ballad Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: October 12, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2024-12

Locations

US (1)