International Study of High-Risk Patients for Hepatocellular Carcinoma Using Liquid Biopsy

Who can take part

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study and up to 5 years post-study follow up
• Adults aged 18 or older
• Both genders and all ethnicities
• Willingness to give written, informed consent to be enrolled into the database
• Collection of biosamples (serum, plasma, and urine) at each of the 6 months follow up during the study duration
• Individuals already confirmed to have cirrhosis with MELD ≤ 15 from any etiology (chronic HBV, chronic HCV, NASH cirrhosis, etc.)
• For chronic HBV and/or /HCV carrier, with or without on treatment
• Reside in Vietnam or Saudi Arabia at the time of study and provides contact information (email and/or cell phone number for texting)
• No prior or current treatment of HCC
• No cancer history within 5 years
• No participation in a trial for HCC Treatment
• No prior solid organ transplant
• Albumin, Bilirubin, Creatinine and INR labs within past 30 days
• Imaging showing no HCC within 180 days
• Diagnosis of fibrosis and cirrhosis based on: histology, image showing cirrhotic liver with splenomegaly and platelets <120 mm3, or esophageal or gastric varices on endoscopy AND presence of chronic liver disease/Fibroscan/Fib-4/APRI/ARFI. For viral hepatitis, kPa>=9kPa, APRI >=1; for NAFLD/NASH (FIB-4 > 1.3 \& TE > 8kPa)
• No significant hepatic decompensation
• No hepatorenal syndrome
• AFP labs within 180 days irrespective of AFP titer
• Two phone numbers and personal identification numbers (CMND number)
• No known AIDS related diseases
• No significant co-morbid conditions with life expectancy <5 years
• No other cancer(s)

Who cannot take part

• On liver transplantation list or anticipated to be on the liver transplantation list during the study duration
• Taking Vitamin K within 7 days prior to clinic follow or having disease affecting Vitamin K levels
• Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements
• Decompensated cirrhosis (variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, and/or hepatorenal syndrome) or MELD>15
• Any serious or active medical or psychiatric illness, which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol
• Known HIV positive
• Individuals who already have HCC, with or without HCC treatment
• Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)
• Documentation was not adequate