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

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

Inclusion Criteria3

  • 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 Criteria2

  • Lack of informed consent
  • Inflammatory bowel disease

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

View Full Details on ClinicalTrials.gov

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NCT07450612