NCT07450612 Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
| NCT ID | NCT07450612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | San Raffaele University |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2031-01-15 |
Trial Parameters
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Brief 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.
Eligibility 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: * Lack of informed consent * Inflammatory bowel disease
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