Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)

Colorectal cancer (CRC) is one of the most common cancers worldwide and among the leading causes of cancer-related mortality. Early detection substantially improves survival; however, adherence to existing screening strategies remains suboptimal across different regions. CLIMBED is a non-randomized, observational, cross-sectional clinical validation study designed to assess the performance of Epiliquid's Delta-HLD liquid biopsy technology, which detects methylation-based epigenetic biomarkers in plasma using PCR. The study will enroll 3200 participants between 45 and 75 years of age, representing an average-risk CRC population. All participants will undergo screening colonoscopy, which will serve as the gold standard for comparison. The primary endpoints are sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Delta-HLD technology for CRC detection in cfDNA. Secondary endpoints include the capacity of the test to identify precursor lesions. Statistical analysis will be based on ROC curves and AUC to determine diagnostic performance.

Inclusion criteria

• Men and women aged 45-75 years
• Indication of colorectal cancer screening colonoscopy by treating physician

Exclusion criteria

• 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)
• Major trauma, surgery, transfusion in past 30 days
• Current participation in an interventional clinical trial