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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00911196
First received: May 28, 2009
Last updated: September 29, 2011
Last verified: September 2011
History of Changes

May 28, 2009
September 29, 2011
November 2008
March 2009   (final data collection date for primary outcome measure)
  • The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • The prognostic character of the expression of the tumor antigens [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Expression of c-MET in the same hepatocellular carcinoma tumor samples [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00911196 on ClinicalTrials.gov Archive Site
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Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

This retrospective study is based upon the analysis of archived samples and patient-related data already available at the investigational site
Probability Sample

Primary care clinic
Hepatocellular Carcinoma
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.
Group A
Intervention: Other: Retrospective analysis of already archived samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

N/A
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Taiwan,   Thailand
 
NCT00911196
111726
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP