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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: May 28, 2009
Last updated: May 25, 2017
Last verified: May 2017
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.

Condition Intervention
Hepatocellular Carcinoma Other: Retrospective analysis of already archived samples

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens. [ Time Frame: At the time of analysis ]
  • The prognostic character of the expression of the tumor antigens [ Time Frame: At the time of analysis ]
  • Expression of c-MET in the same hepatocellular carcinoma tumor samples [ Time Frame: At the time of analysis ]

Biospecimen Retention:   None Retained
This retrospective study is based upon the analysis of archived samples and patient-related data already available at the investigational site

Enrollment: 200
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00911196

GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Chiangmai, Thailand, 50200
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00911196     History of Changes
Other Study ID Numbers: 111726
Study First Received: May 28, 2009
Last Updated: May 25, 2017

Keywords provided by GlaxoSmithKline:
Expression analysis
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on June 23, 2017