A prospective study to determine the value of screening carriers of hepatitis B surface antigen for virus with core promoter double mutations as a marker of extremely high risk of developing hepatocellular carcinoma. (360G-Wellcome-072058_Z_03_A)

To aim to evaluate screening of individuals who are persistent carriers of hepatitis B surface antigen (HBsAg) for hepatitis B virus (HBV) with core promoter double mutations as a marker to identify those at extremely high risk of developing hepatocellular carcinoma (HCC). Our objective is to improve the effectiveness and reduce the costs of early diagnosis of HCC so that more lives can be saved by the surgical resection of early-stage tumours. We propose a prospective study of 3000 HBsAg-positive individuals aged 30-35 from southern Guangxi, China, a region with a very high annual incidence of HCC. The subjects will be divided into three groups: 1) viraemic with core promoter mutations, 2) viraemic with wild type virus and 3) non-viraemic. Every six months, their livers will be examined by ultrasonography and serum alpha-fetoprotein levels will be determined in order to diagnose HCC. Data will be analysed using Poisson regression methods to test whether or not the incidence in the three groups is significantly different, after adjusting for possible confounding variables.