Blood test for early detection of colorectal cancer and adenomas
A Liquid Biopsy Assay For The Non-Invasive Early Detection of Advanced Adenomas and Colorectal Cancer
This study is testing a new blood test to see if it can help find early signs of colorectal cancer and adenomas in people who are already scheduled for a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 6 sites (Monrovia, California and 5 other locations) |
| Trial ID | NCT06342440 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a highly sensitive and cost-effective blood assay for the early detection of colorectal adenomas and cancer using advanced machine learning techniques and biological analyses. Colorectal cancer is a major health concern, and traditional screening methods often miss precursor lesions like adenomas. The proposed liquid biopsy test seeks to provide a non-invasive alternative that can detect both conditions from a single blood draw, thereby improving patient compliance and resource allocation. Participants will have undergone a colonoscopy, and blood samples will be collected prior to any curative treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have undergone a colonoscopy and are at risk for colorectal cancer or adenomas.
Not a fit: Patients with hereditary colorectal cancer syndromes or inflammatory bowel diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could significantly improve early detection rates of colorectal cancer and adenomas, potentially reducing mortality associated with these conditions.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach targeting colorectal adenomas and cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All individuals included in the study need to have had a colonoscopy at the time of blood sampling. * Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment. * Received standard pathological and endoscopic diagnosis and assessment for cohort assignment. Exclusion Criteria: * Hereditary colorectal cancer syndromes (identified through genetic testing). * Inflammatory bowel diseases. * Lack of written informed consent.
Where this trial is running
Monrovia, California and 5 other locations
- City of Hope Medical Center — Monrovia, California, United States (Recruiting)
- University of California San Diego — San Diego, California, United States (Recruiting)
- The First Affiliated Hospital of Dalian Medical University — Dalian, China (Recruiting)
- IRCCS San Raffaele — Milan, Italy (Recruiting)
- Mie University — Mie, Japan (Recruiting)
- Barcelona University — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: AJGOEL@COH.ORG
- Phone: 6262183452
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.