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Blood Test Using Liquid Biopsy and Machine Learning to Detect Early Colorectal Cancer, Adenomas, Lynch Syndrome Cancers, and Monitor Residual Disease

Led by San Raffaele University · Updated on 2026-03-04

1200

Participants Needed

4

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a blood test called a liquid biopsy for early detection of colorectal cancer CRC, advanced adenomas AAs, and cancers associated with Lynch syndrome. This study aims to improve current screening methods, which have limitations such as invasiveness, cost, and low sensitivity for early disease stages. The study also plans to assess the blood tests use for monitoring molecular residual disease after treatment. The study involves collecting blood samples from different groups including individuals with Lynch syndrome with or without associated cancers, patients with sporadic colorectal cancer or advanced adenomas, and controls with negative colonoscopy results. The test analyzes circulating cell-free and exosome-bound microRNAs using machine learning to distinguish cancer and precancerous conditions from controls. Some participants with cancer or adenomas may also be studied before and after surgical treatment to monitor disease persistence. Participants will undergo blood draws and colonoscopy as part of their routine care. Blood samples will be analyzed using reverse transcription, quantitative polymerase chain reaction RT-qPCR, and machine-learning models. Researchers will measure the tests sensitivity, specificity, and accuracy in detecting disease. The study collects data prospectively and follows strict guidelines to ensure unbiased evaluation. Participation duration varies, with some individuals contributing samples before and after treatment for additional analyses.

CONDITIONS

Brief Title

Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection

Research Team

G

Giulia Martina Cavestro, MD, PhD

G

Giulia Martina Cavestro

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