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

ConditionsColorectal 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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSan Raffaele University

About this trial

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

Qualifiers

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

Disqualifiers

Lack of informed consent

Inflammatory bowel disease

Trial design

Treatments tested in this trial

BEACON

Treatment groups

1,200 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Locations

Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital20132, MilanLombardy, Italy

Prof Giulia Martina Cavestro, MD PhD20132, MilanLombardy, Italy

San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit20132, MilanLombardy, Italy

Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori MilanMI, Italy

Sponsors and collaborators

San Raffaele University

Lead sponsor

Source ClinicalTrials.gov