Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Italy
Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori
NOT_YET_RECRUITING
Milan
Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital
NOT_YET_RECRUITING
Milan
Prof Giulia Martina Cavestro, MD PhD
NOT_YET_RECRUITING
Milan
San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit
RECRUITING
Milan
Contact Information
Primary
Giulia Martina Cavestro, MD, PhD
cavestro.giuliamartina@hsr.it
0226437217
Backup
Giulia Martina Cavestro
cavestro.giuliamartina@hsr.it
0226437217
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2031-08-15
Participants
Target number of participants: 1200
Treatments
Lynch syndrome, without Lynch-syndrome associated cancers
Individuals with Lynch syndrome, who are free of Lynch-syndrome associated cancers at the time of blood drawing
Lynch syndrome, with Lynch-syndrome associated cancers
Individuals with Lynch syndrome, who have one (or more) Lynch-syndrome associated cancer(s) at the time of blood drawing
Colorectal cancer
Individuals with sporadic biopsy-proven colorectal cancer, as identified during routine colonoscopy and diagnosed via pathological review
Advanced adenoma
Individuals with sporadic advanced adenomas, defined as (i) more than 3 colorectal polyps, (ii) presence of high-grade dysplasia in one or more polyp, or (iii) polyp(s) \>10 mm
Colonoscopy-negative controls
Individuals whose colonoscopy was negative for colorectal cancer and for advanced colorectal adenomas
Pre-treatment samples
Individuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection)
Post-treatment samples
Individuals with (i) colorectal cancer, or (ii) advanced adenomas, or (iii) Lynch syndrome associated cancer(s) will have the possibility to participate to a sub-analysis of this study, where their circulating plasma levels of biomarkers will be evaluated prior to resection (treatment-naive) and post-resection (to measure the molecular persistence of the disease after the resection)
Related Therapeutic Areas
Sponsors
Leads: San Raffaele University