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

Cancer Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119425
• Other study ID #: 2082244-1
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: Ballad Health
• Contact: Charlie Mayes, PhD
• Phone: 423-431-5654
• Email: Charles.Mays[@]balladhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Colon
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johnson City Medical Center	Johnson City	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Ballad Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opted to be screened by either SOC or study diagnostic test		3 months
Secondary	Opted to be screened by the study diagnostic test instead of SOC		3 months