Liquid biopsy and machine learning to detect early colorectal cancer, advanced adenomas, Lynch-related cancers, and residual disease
Official title: Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
Run by San Raffaele University · NCT07450612 · Data updated 2026-11-12
This project will test a blood-based liquid biopsy that uses microRNA signals and machine learning to detect colorectal cancer, advanced adenomas, Lynch-associated cancers, and molecular residual disease in people who have a colonoscopy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | San Raffaele University Academic / other |
| Locations | 4 sites (Milan, Lombardy and 3 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | January 15, 2031 |
| Study ends | August 15, 2031 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT07450612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people undergoing colonoscopy who can provide informed consent, have blood drawn before any curative-intent treatment, and do not have inflammatory bowel disease.
✕Probably not a fit
People with inflammatory bowel disease, those who cannot or will not have a colonoscopy at the time of blood sampling, or those who already received curative treatment prior to the blood draw are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BEACON/2026 is a multicenter observational effort that collects blood at the time of colonoscopy to develop and validate two blood-based tests: a screening test for CRC and advanced adenomas and a multi-cancer early detection (MCED) test tailored to the Lynch syndrome spectrum. The approach combines cell-free microRNAs (cf-miRNAs) and exosome-bound microRNAs (exo-miRNAs) with machine-learning classifiers to improve sensitivity and specificity. Participants must have blood drawn before any curative-intent treatment and will be assigned to cohorts based on standard pathological and endoscopic diagnoses, with cases compared to controls to estimate diagnostic accuracy. A pre-planned analysis will also evaluate the test's use for molecular residual disease (MRD) monitoring following standard diagnostic and staging procedures.
Why it matters
Potential benefit: If successful, this could offer a less invasive blood test that detects both cancers and pre-cancerous adenomas earlier and enable monitoring for residual disease and Lynch-related tumors.
How similar studies have gone: Similar liquid-biopsy and machine-learning approaches have shown promise in early research for cancer detection and MRD, but blood tests sensitive for advanced adenomas and Lynch-spectrum cancers remain largely experimental.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit
Milan, Lombardy, Italy Recruiting -
Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital
Milan, Lombardy, Italy Not yet recruiting -
Prof Giulia Martina Cavestro, MD PhD
Milan, Lombardy, Italy Not yet recruiting -
Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori
Milan, Mi, Italy Not yet recruiting
Study contacts
- Principal investigator: Giulia Martina Cavestro, MD, PhD — IRCCS San Raffaele Hospital
- Study coordinator: Giulia Martina Cavestro, MD, PhD
- Email: cavestro.giuliamartina@hsr.it
- Phone: 0226437217
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.