Between January 2004 and September 2006, consecutive patients with cirrhosis but no detectable hepatocellular carcinoma (HCC) were prospectively identified and entered into a surveillance programme using ultrasound and α-fetoprotein (AFP), as has been previously described in greater detail.6 (link) Patients were enrolled if they had a Child-Pugh class A or B cirrhosis and absence of known HCC at the time of initial evaluation. Patients diagnosed with HCC within the first 6 months of enrolment (prevalent cases) were excluded. Other exclusion criteria included clinical evidence of significant hepatic decompensation (refractory ascites, grades 3 and 4 encephalopathy, active variceal bleeding or hepatorenal syndrome), comorbid medical conditions with a life expectancy of less than 1 year, prior solid organ transplant and a known extrahepatic primary tumour. Patients were followed until the time of HCC diagnosis, liver transplantation, death or until the study was terminated on 31 July 2010.
The following demographic and clinical data were collected at the time of enrolment: age, gender, race, body mass index (BMI), medical history, lifetime alcohol use and lifetime tobacco use. Data regarding their liver disease included the underlying aetiology and presence of ascites, encephalopathy or oesophageal varices. Laboratory data of interest at the time of enrolment included platelet count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, bilirubin, albumin, international normalised ratio (INR) and AFP. This data set was used as the basis of a published predictive model to identify patients with hepatocellular carcinoma with a c statistic of 0.70.2