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

RECRUITING

NCT07450612

Sponsor: San Raffaele University

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1200

Start Date

2024-01-01

Completion Date

2031-08-15

Last Updated

2026-03-04

Healthy Volunteers

Yes

Conditions

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-specific Colonic Cancer)LYN Gene Mutation Mismatch Repair Deficiency Mismatch Repair Gene Mutation MLH1 Gene Mutation MSH2 Gene Mutation MSH6 Gene Mutation PMS2 Gene Mutation EPCAM Gene Mutation

Interventions

DIAGNOSTIC_TEST

BEACON

A panel of circulating microRNA, whose expression level is tested in cell-free and exosome-derived samples

Locations (4)

Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital

Milan, Lombardy, Italy

Prof Giulia Martina Cavestro, MD PhD

Milan, Lombardy, Italy

San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit

Milan, Lombardy, Italy

Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori

Milan, MI, Italy

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