RecruitingNCT07450612

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


Sponsor

San Raffaele University

Enrollment

1,200 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and validating a blood test called liquid biopsy — which detects cancer-related DNA fragments in the bloodstream — combined with machine learning (AI) to detect colorectal cancer, pre-cancerous polyps (adenomas), Lynch syndrome-related cancers, and residual cancer after treatment, earlier and more accurately than current methods. **You may be eligible if:** - You have had a colonoscopy around the time your blood sample is being taken - You have received standard diagnostic procedures and had at least one blood sample collected before any cancer treatment began - You have received standard pathological testing and have been assigned to a diagnostic group in the study **You may NOT be eligible if:** - You are unable or unwilling to provide informed consent - You have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBEACON

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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NCT07450612


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