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

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for theduration of the study and up to 5 years post-study follow up

3. Adults aged 18 or older

4. Both genders and all ethnicities

5. Willingness to give written, informed consent to be enrolled into the database

6. Collection of biosamples (serum, plasma, and urine) at each of the 6 months followup during the study duration

7. Individuals already confirmed to have cirrhosis with MELD ≤ 15 from any etiology (chronic HBV, chronic HCV, NASH cirrhosis, etc.)

8. For chronic HBV and/or /HCV carrier, with or without on treatment

9. Reside in Vietnam or Saudi Arabia at the time of study and provides contactinformation (email and/or cell phone number for texting)

10. No prior or current treatment of HCC

11. No cancer history within 5 years

12. No participation in a trial for HCC Treatment

13. No prior solid organ transplant

14. Albumin, Bilirubin, Creatinine and INR labs within past 30 days

15. Imaging showing no HCC within 180 days

16. Diagnosis of fibrosis and cirrhosis based on: histology, image showing cirrhoticliver with splenomegaly and platelets <120 mm3, or esophageal or gastric varices onendoscopy AND presence of chronic liver disease/Fibroscan/Fib-4/APRI/ARFI. For viralhepatitis, kPa>=9kPa, APRI >=1; for NAFLD/NASH (FIB-4 > 1.3 & TE > 8kPa)

17. No significant hepatic decompensation

18. No hepatorenal syndrome

19. AFP labs within 180 days irrespective of AFP titer

20. Two phone numbers and personal identification numbers (CMND number)

21. No known AIDS related diseases

22. No significant co-morbid conditions with life expectancy <5 years

23. No other cancer(s)

Exclusion Criteria:

1. Decompensated cirrhosis (variceal bleeding, hepatic encephalopathy, ascites,spontaneous bacterial peritonitis, and/or hepatorenal syndrome) or MELD>15

2. Individuals who already have HCC, with or without HCC treatment

3. On liver transplantation list or anticipated to be on the liver transplantation listduring the study duration

4. Individuals who cannot, do not want to, or refused to sign the informed consent form (ICF)

5. Any serious or active medical or psychiatric illness, which, in the opinion of theinvestigator, would interfere with patient treatment, assessment or compliance withthe protocol

6. Documentation was not adequate

7. Taking Vitamin K within 7 days prior to clinic follow or having disease affectingVitamin K levels.

8. Known HIV positive

9. Active drug use or dependence that, in the opinion of the study investigator, wouldinterfere with adherence to study requirements