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.
Age range
40 Years – 90 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
Timeframe: Baseline and every 6 months thereafter, and at HCC diagnosis every 6 months thereafter up to 70 months.
value of cT1, PDFF and T2* levels to predict individual's risk of developing and progression of HCC.
Timeframe: Baseline and upon elevated AFP or US which is suggestive of HCC, up to 70 months.
Changes in the profile of gut microbiota as high-risk patients develop HCC.
Timeframe: Baseline and every 6 months thereafter, up to 70 months
Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.
Timeframe: Baseline and every 6 months thereafter, up to 70 months.