Early Onset Colorectal Cancer Detection
Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer
City of Hope Medical Center
400 participants
Apr 15, 2023
OBSERVATIONAL
Conditions
Summary
Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women. This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)
Eligibility
Inclusion Criteria3
- Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 (EOCRC cases)
- Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment
- Colonoscopy-proven cancer-free status at the time of study inclusion (Non-disease controls)
Exclusion Criteria3
- Hereditary colorectal cancer syndromes (identified through genetic testing)
- Inflammatory bowel diseases
- Lack of written informed consent
Interventions
A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT06342401