Stool DNA and occult blood testing for screen detection of colorectal neoplasia.
David A Ahlquist, Daniel J Sargent, Charles L Loprinzi...
https://pubmed.ncbi.nlm.nih.gov/18838724Actively Recruiting
Led by San Raffaele University · Updated on 2026-03-04
1200
Participants Needed
4
Research Sites
30 weeks
Total Duration
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
Liquid Biopsy and Machine Learning for Early Colorectal Cancer, Adenomas, Lynch Cancers, and Residual Disease Detection
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
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
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
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
G
Giulia Martina Cavestro, MD, PhD
G
Giulia Martina Cavestro
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
7
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