Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma

Brief Summary

Official Title: “Analysis of the Incidence of Expression of Tumor Antigens and Tumor Marker in Cancer Tissue From Asian Patients With Hepatocellular Carcinoma and Evaluation of Prognostic Significance of These Tumor Antigens.”

Hepatocellular carcinoma is an aggressive disease with limited therapeutic options. Therefore, new approaches to treat this type of cancer are needed with immunotherapy potentially being one of these. As a first step in the development of novel therapies, expression analysis of specific markers, including tumor antigens will be carried out, and the correlation of expression with disease variables and clinical outcome will be assessed. This will be done retrospectively using archived hepatocellular carcinoma tissue samples.

  • Study Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Retrospective
  • Study Primary Completion Date: March 2009

Interventions Used in this Clinical Trial

  • Other: Retrospective analysis of already archived samples
    • Analysis using RNA extracted from tissue samples already archived; Analysis by Fluorescent in situ hybridization (FISH) using tissue samples already archived.

Arms, Groups and Cohorts in this Clinical Trial

  • Group A

Outcome Measures for this Clinical Trial

Primary Measures

  • The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens.
    • Time Frame: At the time of analysis
      Safety Issue?: No
  • The prognostic character of the expression of the tumor antigens
    • Time Frame: At the time of analysis
      Safety Issue?: No
  • Expression of c-MET in the same hepatocellular carcinoma tumor samples
    • Time Frame: At the time of analysis
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • The patient has pathologically proven hepatocellular carcinoma (any stage)
  • All the data required are available from patient's records

Exclusion Criteria

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline


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