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Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00858000
First received: March 5, 2009
Last updated: December 23, 2009
Last verified: December 2009
History of Changes

March 5, 2009
December 23, 2009
July 2009
December 2009   (final data collection date for primary outcome measure)
  • This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor. [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
  • Proportion of hepatocellular carcinoma cancer patients whose tumor tissue -expresses any one or more of specific target antigens -overexpresses c-MET -expresses a pre-defied gene-expression signature [ Time Frame: At the time of analysis. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00858000 on ClinicalTrials.gov Archive Site
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Analysis of Expression of Specific Markers in Hepatocellular Carcinoma
Analysis of the Incidence of Expression of a Specific Set of Genes and of Tumor Antigens in Cancer Tissue From Patients With Hepatocellular Carcinoma

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. This will be done retrospectively using available 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
Non-Probability Sample

Primary care clinic
Hepatocellular Carcinoma
Other: Retrospective analysis of already archived samples
RNA extracted from tissue samples already archived
Group A
No intervention
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
30
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient had pathologically proven hepatocellular carcinoma
  • All the data required are available from patient's records
  • A sufficient amount of RNA is available for all three tissue samples

Exclusion Criteria:

N/A
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00858000
111722
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2009

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