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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00911196
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment
Hepatocellular Carcinoma Other: Retrospective analysis of already archived samples

Study Type : Observational
Actual Enrollment : 200 participants
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.
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens. [ Time Frame: At the time of analysis ]
  2. The prognostic character of the expression of the tumor antigens [ Time Frame: At the time of analysis ]
  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: GlaxoSmithKline Identifier: NCT00911196     History of Changes
Other Study ID Numbers: 111726
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 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