CLIMBED (Colon cancer Liquid biopsy Investigation of Methylation-based Biomarkers Evaluation using Delta-HLD) is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Delta-HLD, Epiliquid's proprietary liquid biopsy technology, for colorectal cancer (CRC) detection. The study will evaluate the test performance in an average-risk population for CRC undergoing screening colonoscopy, which will serve as the gold standard reference.
Men and women aged 45-75 years
Indication of colorectal cancer screening colonoscopy by treating physician
First-degree family history of CRC
Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
Other malignancies within 5 years
Known hereditary CRC syndromes (Lynch, FAP)
Single cohort of adults aged 45 and 75 years, representing an average-risk CRC population, undergoing routine colorectal cancer screening with colonoscopy in Argentina as standard of care.
Cohort
Cross-sectional
Not listed
Sensitivity of colorectal cancer detection
Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer
Specificity of advanced neoplasia detection
Specificity of colorectal cancer detection
Accuracy of colorectal cancer precursor lesions detection
Sensitivity and specificity of of colorectal cancer precursor lesions detection
Predictive values
Positive predictive value (PPV) and negative predictive value (NPV) of the Delta-HLD test for CRC detection
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