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Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)
Sponsor: National Cancer Centre, Singapore
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