Colon Cancer Liquid Biopsy Investigation of Methylation-based Biomarkers Evaluation Using Delta-HLD (CLIMBED)

NCT07168876 | Recruiting

• 2 other identifiers: CRC-CVRENIS IS004624
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer (CRC)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity of colorectal cancer detection

  Sensitivity and specificity of the Delta-HLD test for detection of colorectal cancer

  18 months

• Specificity of advanced neoplasia detection

  Specificity of colorectal cancer detection

  36 months

Secondary Outcomes (2)

• Accuracy of colorectal cancer precursor lesions detection

  36 months

• Predictive values

  36 months

Study Arms (1)

Cases: Average-risk population undergoing colorectal cancer screening colonoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single cohort of adults aged 45 and 75 years, representing an average-risk CRC population, undergoing routine colorectal cancer screening with colonoscopy in Argentina as standard of care.

You may qualify if:

• Men and women aged 45-75 years
• Indication of colorectal cancer screening colonoscopy by treating physician

You may not qualify if:

• 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

Sponsors & Collaborators

• Epiliquid Holding, Inc: lead

Study Sites (1)

Epiliquid

Mendoza, Mendoza Province, 5500, Argentina

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples will be collected and retained for analysis. Circulating cell-free DNA (cfDNA) will be extracted from plasma and stored for future validation studies. No other sample types will be retained.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Emanuel Campoy, PhD

  CONICET-National Scientific and Technical Research Council

  STUDY DIRECTOR

Central Study Contacts

Dr. Victoria Bocanegra, MD, PhD.

CONTACT

+5492616603254; victoria.bocanegra@epiliquid.com

Dr. Emanuel Campoy, PhD.

CONTACT

+5492615997899; emanuel.campoy@epiliquid.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: April 4, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)