Blood test that looks for DNA methylation to detect colorectal cancer using Delta-HLD

Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)

This will test a blood-based DNA methylation assay called Delta-HLD to see if it can detect colorectal cancer in people aged 45–75 undergoing routine screening colonoscopy.

Quick facts

• Study type: Observational
• Enrollment: 3200 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Epiliquid Holding, Inc (industry)
• Locations: 1 site (Mendoza, Mendoza Province)
• Trial ID: NCT07168876 on ClinicalTrials.gov

What this trial studies

CLIMBED is a non-randomized, observational, cross-sectional validation enrolling 3,200 average-risk adults aged 45–75 who are scheduled for screening colonoscopy. Each participant provides a plasma sample for Epiliquid's Delta-HLD PCR-based methylation assay, and test results are compared against colonoscopy as the gold standard. Primary endpoints are sensitivity, specificity, positive predictive value, and negative predictive value for CRC detection in cfDNA, with secondary endpoints assessing detection of precursor lesions. Diagnostic performance will be quantified using ROC curves and AUC analyses.

Who should consider this trial

Good fit: Ideal candidates are average-risk adults aged 45–75 who are scheduled for screening colonoscopy and do not have high-risk conditions such as a first-degree family history of CRC, inflammatory bowel disease, recent other malignancy, known hereditary CRC syndromes, recent major surgery/trauma/transfusion, or current participation in an interventional trial.

Not a fit: People with active inflammatory bowel disease, a first-degree family history of CRC, known hereditary CRC syndromes, recent other cancers, recent major surgery/trauma/transfusion, or current enrollment in interventional trials are excluded and unlikely to benefit from this validation.

Why it matters

Potential benefit: If successful, the Delta-HLD blood test could make CRC screening simpler and more accessible by identifying cancers or precursors from a single plasma sample.

How similar studies have performed: Other methylation-based cfDNA tests have shown promise for colorectal cancer detection in past studies, but performance varies by assay and population, so this is a validation of a specific proprietary method.

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

Where this trial is running

Mendoza, Mendoza Province

• Epiliquid — Mendoza, Mendoza Province, Argentina (RECRUITING)

Study contacts

• Study coordinator: Dr. Victoria Bocanegra, MD, PhD.

Conditions: Colorectal Cancer, Colorectal cancer, Epigenetics, Liquid biopsy, cfDNA, Biomarker, Methylarion, PCR