Blood test for colorectal cancer screening in average risk patients
Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice in the Outpatient Clinical Settings in the Appalachian Highlands
This study is testing a blood test for colorectal cancer screening in average-risk patients aged 45-84 to see if it’s easy for them to use and helps more people get screened.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 45 Years to 84 Years |
| Sex | All |
| Sponsor | Ballad Health Academic / other |
| Locations | 1 site (Johnson City, Tennessee) |
| Trial ID | NCT06119425 on ClinicalTrials.gov |
What this trial studies
This prospective implementation study aims to evaluate the integration of a blood-based colorectal cancer (CRC) screening test into primary care and internal medicine settings. It targets patients aged 45-84 who are considered average risk for CRC according to USPSTF guidelines and have opted for screening. The study will assess patient acceptability and adherence to this noninvasive screening method, as well as provider experiences and implementation behaviors. By addressing the barriers to CRC screening, the study seeks to improve participation rates and ultimately enhance early detection of colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-84 who are considered average risk for colorectal cancer and willing to participate in blood-based screening.
Not a fit: Patients with a personal history of colorectal cancer, known high-risk family history, or current symptoms of CRC will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to increased participation in colorectal cancer screening, facilitating earlier detection and better patient outcomes.
How similar studies have performed: Other studies have shown promise in using noninvasive screening methods for colorectal cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Johnson City, Tennessee
- Johnson City Medical Center — Johnson City, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Karen J. Elmore, MD — Ballad Health
- Study coordinator: Charlie Mayes, PhD
- Email: Charles.Mays@balladhealth.org
- Phone: 423-431-5654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.