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.
Eligible patients will receive 6-monthly standard-of-care surveillance (US, serum AFP and liver function test) for HCC until end of study or up to a maximum of 7 assessments (1 baseline and 6 follow-up assessments). There will be an option for patients to continue to receive standard-of-care surveillance for HCC until end of study or up to 6 additional assessments (Visits 8-13), whichever occurs first. Patients with elevated AFP or abnormalities detected on US will be investigated with multi-phasic CT scan or MRI to confirm or refute the diagnosis of HCC. Additionally, patients shall be scheduled for sequential bio-samples collection (blood, urine and stool) and blood tests (Hba1c and Lipid Panel) during the course of the study.
Study Type
OBSERVATIONAL
Enrollment
2,002
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
...and 4 more locations
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
Changes in the profile of circulating micro-RNA biomarkers as high-risk patients develop HCC
Time frame: 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.
value of cT1, PDFF and T2\* levels to predict individual's risk of developing and progression of HCC.
Time frame: 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.
Changes in the profile of gut microbiota as high-risk patients develop HCC.
Time frame: 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.
Changes in the profile of metabolome in urine and plasma as high-risk patients develop HCC.
Time frame: Baseline and every 6 months thereafter, up to 70 months.
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