Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer (CRC). Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)
Overview
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.
Detailed description
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.
Primary outcome measures
- Sensitivity of colorectal cancer detection [Time frame: 18 months]
- Specificity of advanced neoplasia detection [Time frame: 36 months]
Secondary outcome measures (2)
- Accuracy of colorectal cancer precursor lesions detection [Time frame: 36 months]
- Predictive values [Time frame: 36 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Argentina · 1 center
- Epiliquid — Mendoza
Identifiers
NCT: NCT07168876 · CRC-CV · RENIS IS004624