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NCT04965259

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

Sponsor: National Cancer Centre, Singapore

View on ClinicalTrials.gov

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.

Official title: Early Detection of Hepatocellular Carcinoma (HCC): miRNA, Microbiome and Imaging Biomarkers in the Evolution of Chronic Liver Disease in a High-risk Prospective Cohort (ELEGANCE)

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

2002

Start Date

2021-04-15

Completion Date

2026-12-21

Last Updated

2025-07-02

Healthy Volunteers

No

Conditions

Locations (14)

National University Hospital

Singapore, Singapore

SingHealth Polyclinics - Bukit Merah

Singapore, Singapore

National Cancer Center Singapore

Singapore, Singapore

SingHealth Polyclinics - Outram

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

SingHealth Polyclinics - Marine Parade

Singapore, Singapore

SingHealth Polyclinics - Bedok

Singapore, Singapore

SingHealth Polyclinics - Pasir Ris

Singapore, Singapore

SingHealth Polyclinics - Tampines

Singapore, Singapore

Changi General Hospital

Singapore, Singapore

Sengkang General Hospital

Singapore, Singapore

SingHealth Polyclinics - Sengkang

Singapore, Singapore

SingHealth Polyclinics - Punggol

Singapore, Singapore