MedTrace Logo

Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)

NCT04965259 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2002

Last updated 2025-07-02

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage.

This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic (IVD) kit for the detection of early HCC in a cohort of high-risk patients.

Additionally, this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance. Lastly, by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC.

Conditions

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Singapore Phenome Centre

    collaborator UNKNOWN

  • Nanyang Technological University

    collaborator OTHER

  • MiRXES Pte Ltd

    collaborator INDUSTRY

  • Perspectum Asia Pte Ltd

    collaborator UNKNOWN

  • Asian Microbiome Library Pte Ltd

    collaborator UNKNOWN

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Pierce Chow, MD, PhD · National Cancer Centre, Singapore

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2025-03-11
Completion
2026-12-21

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965259 on ClinicalTrials.gov