Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, a
This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for
| Condition(s) | Colorectal Cancer, Adenoma Colon, Adenoma Colon Polyp, Colon Adenoma, Colo-rectal Cancer, Colon Disease, Colon Neoplasm, Lynch Syndrome, Lynch Syndrome I, Lynch Syndrome II, Lynch Syndrome I (Site-spe |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This is an multicenter study that will test the diagnostic accuracy of a blood test (i.e., a liquid biopsy) for the diagnosis of colorectal cancer (CRC), advanced adenomas (AAs), as well as Lynch-syndrome associated cancers. Additionally, a pre-planned analysis will evaluate the use of this liquid biopsy as a tool for molecular residual disease monitoring purposes. |
| Who can participate | 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: * Lack of informed consent * Inflammatory bowel disease |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | San Raffaele University |
| Locations | Milan, Lombardy, Italy; Milan, Lombardy, Italy; Milan, Lombardy, Italy; Milan, MI, Italy |
| Start date | 2024-01-01 |
| NCT ID | NCT07450612 |
| Official listing | https://clinicaltrials.gov/study/NCT07450612 |