Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
Recruiting · NCT07450612 · Observational (researchers observe without assigning treatment) · Lead sponsor: San Raffaele University
View the official record on ClinicalTrials.gov →Interventions studied
BEACON
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Lack of informed consent
- Inflammatory bowel disease
Where it is running
4 locations listed.
- 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