Blood test that looks for DNA methylation to detect colorectal cancer using Delta-HLD
Official title: Clinical Validation Cross-sectional Study for Colorectal Cancer Assessment Using Delta-HLD Technology (CLIMBED)
Run by Epiliquid Holding, Inc · NCT07168876 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 45 Years to 75 Years |
| Sex | All |
| Enrollment | 3200 (estimated) |
| Sponsor | Epiliquid Holding, Inc Industry-sponsored |
| Locations | 1 site (Mendoza, Mendoza Province) |
| Status | Recruiting |
| Started | April 4, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2028 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT07168876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Epiliquid
Mendoza, Mendoza Province, Argentina Recruiting
Study contacts
- Study coordinator: Dr. Victoria Bocanegra, MD, PhD.
- Email: victoria.bocanegra@epiliquid.com
- Phone: +5492616603254
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.