Clinical trial · Observational
Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)
Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cases: Average-risk population undergoing colorectal cancer screening colonoscopy
Primary outcomes (2)
- measure
- Sensitivity of colorectal cancer detection
- timeFrame
- 18 months
- description
- Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer
- measure
- Specificity of advanced neoplasia detection
- timeFrame
- 36 months
- description
- Specificity of colorectal cancer detection
Secondary outcomes (2)
- measure
- Accuracy of colorectal cancer precursor lesions detection
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available