CASCADE (Colorectal Analysis for Signature Cancer Assessment Using delta-HLD Technology) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy technology, for the detection of colorectal cancer. Epiliquid also integrates a proprietary bioinformatic system capable of identifying, ranking, and selecting tumor-specific methylation biomarkers for different cancer types. In this study, colorectal cancer-specific biomarkers will be evaluated in blood and tissue samples using delta-HLD technology, which enables sensitive and multiplexed detection through PCR. Study results will support the validation of Epiliquid's integrated platform as a minimally invasive and accessible diagnostic solution for colorectal cancer.

This observational case-control study aims to evaluate the performance of delta-HLD technology in an average-risk colorectal cancer population. The CASCADE study seeks to validate the technical and diagnostic performance of Epiliquid's platform, which integrates a proprietary bioinformatic system designed to identify, rank, and select methylation-based biomarkers specific to each cancer type. For colorectal cancer, these biomarkers are selected and detected using delta-HLD technology, a proprietary method that combines sequential enzymatic pre-treatment with PCR-based amplification to enable sensitive, multiplexed detection. Blood (plasma cfDNA) and tumor tissue samples will be collected from two groups: individuals with histologically confirmed colorectal cancer (cases) and individuals with negative colonoscopy findings (controls). This proof-of-concept study will assess biomarker performance, including sensitivity, specificity, and concordance between blood and tissue samples.

Inclusion Criteria:

• Candidate for colonoscopy or colorectal surgery
• Willing and able to provide informed consent
• Able to provide blood and/or tissue sample before treatment or resection

Exclusion Criteria:

• Prior history of colorectal cancer
• Inflammatory bowel disease
• Known hereditary cancer syndromes (e.g., Lynch, FAP)
• Other active malignancies
• Recent chemotherapy or immunosuppressive treatment

Adults aged 45 to 75 years from an average-risk population for colorectal cancer, undergoing colonoscopy or colorectal surgery at participating clinical sites in Argentina.