20 In the majority of other human cancers, such as prostate,21–23 breast,24–26 lung,27 bladder28 and colon29 cancers, however, upregulated expression of clusterin was frequently detected. In HCC, it was reported that 89% of HCC cases exhibited clusterin overexpression in neoplastic BYL719 molecular weight cells as detected by immunohistochemical staining,30 and recently, we have found that an increased expression of clusterin in metastatic HCC tissues when compared with that in primary HCC tissues of the same patients.31 These data suggested that changed expression (upregulated or downregulated) of clusterin may play

an important role in the tumorigenesis of several types of human cancer, including HCC. In view of the possible diagnostic role of clusterin in the development and/or progression of HCC, in the

present study, we developed a sandwich enzyme-linked immunosorbent assay (ELISA) to determine the serum clusterin concentrations in a cohort of HCC patients and control subjects (i.e, Wnt cancer healthy subjects, HBV carriers, chronic hepatitis B and liver cirrhosis patients) and thus, to evaluate the correlation and potential usefulness of this marker in screening patients at risk of HCC. A total of 184 adults at the Cancer Center and the First Affiliated Hospital, Sun Yat-Sen University, China between November 2002 and September 2007 were enrolled in this study. All subjects gave their informed consent to the study, which was approved by the local ethics committee. These subjects were set into five groups according to different clinical characteristics (Table 1). Group 1(G1): Healthy subjects. This group included 22 healthy blood donors with no history of liver disease. All subjects had a normal liver biochemistry. Group 2(G2): HBV carriers. This group included 31 patients with HBV infection. With regard to etiology, HBV was diagnosed

by positive serum surface antigen for HBV. Group 3(G3): Patients with chronic hepatitis B. This group included 26 patients with mild to severe chronic hepatitis B. These patients had no sign of liver cirrhosis or any tumors according to clinical, biochemical new and imaging criteria. Group 4(G4): Patients with liver cirrhosis. This group included 29 patients with HBV-related liver cirrhosis. The diagnosis of liver cirrhosis was established on the basis of clinical, biochemical, imaging (US and computed tomography [CT]) and histological examinations. All patients underwent clinical evaluation, routine laboratory investigation, assessment of circulating levels of AFP and liver US. Group 5(G5): HCC patients. This group included 76 HCC patients with HBV-related liver cirrhosis. HCC was diagnosed histologically when the surgical liver specimens were available.