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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07168876

Acronym

CLIMBED

Enrollment

3200

Registered

2025-09-11

Start date

2024-04-04

Completion date

2028-12-31

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer (CRC)

Keywords

Colorectal cancer, Epigenetics, Liquid biopsy, cfDNA, Biomarker, Methylarion, PCR

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity of colorectal cancer detection	18 months	Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer
Specificity of advanced neoplasia detection	36 months	Specificity of colorectal cancer detection

Secondary

Measure	Time frame	Description
Accuracy of colorectal cancer precursor lesions detection	36 months	Sensitivity and specificity of of colorectal cancer precursor lesions detection
Predictive values	36 months	Positive predictive value (PPV) and negative predictive value (NPV) of the Delta-HLD test for CRC detection

Countries

Argentina

Contacts

Primary ContactDr. Victoria Bocanegra, MD, PhD.

victoria.bocanegra@epiliquid.com+5492616603254

Backup ContactDr. Emanuel Campoy, PhD.

emanuel.campoy@epiliquid.com+5492615997899

Outcome results