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Prospective Cohort Study of Changes in Circulatory MicroRNA of Resected Hepatocellular Carcinoma

NCT05148572 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2025-07-02

No results posted yet for this study

Summary

Hepatocellular carcinoma (HCC) is the 4th most common cause of cancer death globally but only 20% are diagnosed in its early stages where curative treatment can be carried out. 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. In another study (AHCC10 ELEGANCE, NCT04965259), 2,000 patients at risk of developing HCC will be enrolled to develop the 1st miRNA in-vitro diagnostic (IVD) kit for HCC that has higher accuracy and better ease of use compared with the extant combination of AFP and US.

This prospective study will act as a positive control to the AHCC10 ELEGANCE Study and aims to address the absence of efficacious modalities of surveillance by validating a panel of circulating miRNA biomarkers signatures with histologically proven HCC. This study will determine progressive changes in the profiles of miRNA signatures pre- and post- surgical resection to identify signatures predictive of recurrence.

Additionally, this study also aims to identify changes in key metabolites and microbiome with correlation to changes in choline, bile acid and tryptophan metabolic pathways with changes in the composition and function of gut microbiota to establish actionable biomarkers that can predict HCC recurrence.

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

  • Asian Microbiome Library (AMiLi) Pte Ltd

    collaborator UNKNOWN

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

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

Eligibility

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

Timeline & Regulatory

Start
2021-11-10
Primary Completion
2025-04-30
Completion
2026-12-21

Countries

  • Singapore

Study Locations

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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 NCT05148572 on ClinicalTrials.gov