About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Hereditary colorectal cancer syndromes (identified through genetic testing)
Inflammatory bowel diseases
Lack of written informed consent
Trial population
Individuals younger than 50 years of age who were diagnosed with colorectal cancer before the age of 50 (cases) or were free from colorectal cancer at the time of study inclusion (controls)
Trial design
Case-control
Retrospective
Treatments tested in this trial
ENCODE
Diagnostic testA 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.
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Secondary outcomes
Specificity
True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Sponsors and contacts
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