Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07450612

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

Led by San Raffaele University · Updated on 2026-03-04

1200

Participants Needed

4

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a blood test called a liquid biopsy for early detection of colorectal cancer (CRC), advanced adenomas (AAs), and cancers associated with Lynch syndrome. This study aims to improve current screening methods, which have limitations such as invasiveness, cost, and low sensitivity for early disease stages. The study also plans to assess the blood test's use for monitoring molecular residual disease after treatment. The study involves collecting blood samples from different groups including individuals with Lynch syndrome with or without associated cancers, patients with sporadic colorectal cancer or advanced adenomas, and controls with negative colonoscopy results. The test analyzes circulating cell-free and exosome-bound microRNAs using machine learning to distinguish cancer and precancerous conditions from controls. Some participants with cancer or adenomas may also be studied before and after surgical treatment to monitor disease persistence. Participants will undergo blood draws and colonoscopy as part of their routine care. Blood samples will be analyzed using reverse transcription, quantitative polymerase chain reaction (RT-qPCR), and machine-learning models. Researchers will measure the test's sensitivity, specificity, and accuracy in detecting disease. The study collects data prospectively and follows strict guidelines to ensure unbiased evaluation. Participation duration varies, with some individuals contributing samples before and after treatment for additional analyses.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All participants must have had a colonoscopy at the time of blood sampling
  • Must have received standard diagnostic and staging procedures according to local guidelines
  • At least one blood sample must be drawn before any curative-intent treatment
  • Must have received standard pathological and endoscopic diagnosis for study group assignment
Not Eligible

You will not qualify if you...

  • Lack of informed consent
  • Presence of inflammatory bowel disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for blood sampling and colonoscopy confirmation

Diagnostic Evaluation

Duration - Up to 1 year

Participants provide blood samples for liquid biopsy testing to detect colorectal cancer, advanced adenomas, and Lynch syndrome-associated cancers.

Periodic blood draws as part of routine diagnostic and staging procedures

Long-term Monitoring

Duration - Up to 1 year

Participants may have additional blood samples collected before and after treatment to monitor molecular markers related to disease presence and persistence.

Additional blood draws pre-treatment and post-treatment depending on participant subgroup

Trial Site Locations

Total: 4 locations

1

Gastronterology and Gastrointestinal Endoscopy Unit, IRCCS San Raffaele Hospital

Milan, Lombardy, Italy, 20132

Not Yet Recruiting

2

Prof Giulia Martina Cavestro, MD PhD

Milan, Lombardy, Italy, 20132

Not Yet Recruiting

3

San Raffaele Scientific Institute, Gastroenterology and Gastrointestinal Endoscopy Unit

Milan, Lombardy, Italy, 20132

Actively Recruiting

4

Dipartimento di Chirurgia Oncologica e Dipartimento di Oncologia Sperimentale Istituto Nazionale Tumori

Milan, MI, Italy

Not Yet Recruiting

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Research Team

G

Giulia Martina Cavestro, MD, PhD

G

Giulia Martina Cavestro

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

7

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Published Research Related To This Trial

An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study.

Alessandro Mannucci, Francesc Balaguer, Yasuhide Yamada...

https://pubmed.ncbi.nlm.nih.gov/41364052