A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers

• Patient who is able and willing to comply with study procedures, and signed and dated informed consent is obtained.

  • Patients with a clinical suspicion of cirrhosis based on the investigator's evaluation with cirrhosis confirmed by one of the following: (see below for definition of cirrhosis). Etiology of cirrhosis will not be considered in determining inclusion in the study.
  • Patients aged 18 years and older.
  • Hep B Risk Score > 8 (table 1)

Table 1 Variable Risk Score Variable Risk Score Male 2 ALT \<15 0 Female 0 ALT 15-44 1 Age 30-34 0 ALT > 45 2 Age 35-39 1 HBeAg+ve 0 Age 40-44 2 Anti-HBe-positive 2 Age 45-49 3 HBV DNA \<300 copies/mL 0 Age 50-54 4 HBV DNA 300-9999 copies/mL 0 Age 55-59 5 HBV DNA 104 -99,000 copies/mL 3 Age 60-65 6 HBV DNA 105 - 999,999 copies/mL 5 HBV DNA > 106 copies/mL 4

Exclusion Criteria:

• • Patients who have confirmed HCC by CT/MRI when they enrolled. Patients who have previously had HCC but have been treated and have been recurrence free for 5 years are eligible.

    • Patients with the other cancer(s)
    • Pregnant Women
    • Patients who have known diagnosis of mental incapacitation that affects their ability to consent.
    • Patients who are likely to be transplanted within 1 year or MELD score greater than 20.
    • Patients with total or direct bilirubin > 3x upper limit of normal
    • Patients with uncontrollable ascites
    • Glomerular Filtration Rate less than 60.
    • Patients with ≥ Grade II of hepatic encephalopathy
    • Patients who are being treated with warfarin (DCP test values are affected by warfarin)
    • Patients who have any contraindication to any of the study procedures, products used or its constituents (e.g., renal failure or contrast allergy).
    • Patients who suffer from claustrophobia or who have other contraindications to MRI
    • Patients with cirrhosis who were successfully treated for hepatitis C more than 3 years prior. However, patients who are on study who are treated for their hepatitis C may continue in the study.