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

NCT ID: NCT06119425

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2024-10-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

blood-based CRC screening

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ballad Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen J. Elmore, MD

Role: PRINCIPAL_INVESTIGATOR

Ballad Health

Locations

Johnson City Medical Center

Johnson City, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charlie Mayes, PhD

Role: CONTACT

Charles.Mays@balladhealth.org

423-431-5654

Christy Adkins

Role: CONTACT

christy.adkins@balladhealth.org

423-431-5667

Facility Contacts

Charlie Mayes, PhD

Role: primary

Charles.Mays@balladhealth.org

423-431-5654

Christy Adkins

Role: backup

christy.adkins@balladhealth.org

4234315667

Other Identifiers

2082244-1

Identifier Type: -

Identifier Source: org_study_id