NCT07168876 Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)
| NCT ID | NCT07168876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Epiliquid Holding, Inc |
| Condition | Colorectal Cancer (CRC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,200 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2025-12 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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
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