Clinical trial NCT06119425: Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice Highlands
Official title: Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice in the Outpatient Clinical Settings in the Appalachian Highlands
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Colon
Lead sponsor: Ballad Health
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Opted to be screened by either SOC or study diagnostic test
timeFrame: 3 months
Secondary outcomes:
measure: Opted to be screened by the study diagnostic test instead of SOC
timeFrame: 3 months
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: Johnson City Medical Center
state: Tennessee
Study officials:
affiliation: Ballad Health
name: Karen J. Elmore, MD
role: PRINCIPAL_INVESTIGATOR
References: