Analysis of Expression of Specific Markers 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: NCT00858000
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : December 24, 2009
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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. This will be done retrospectively using available hepatocellular carcinoma tissue samples.

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

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analysis of the Incidence of Expression of a Specific Set of Genes and of Tumor Antigens in Cancer Tissue From Patients With Hepatocellular Carcinoma
Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Group/Cohort Intervention/treatment
Group A
No intervention
Other: Retrospective analysis of already archived samples
RNA extracted from tissue samples already archived

Primary Outcome Measures :
  1. 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. ]
  2. 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. ]

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

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

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:

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): NCT00858000

GSK Investigational Site
Firenze, Toscana, Italy, 50134
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00858000     History of Changes
Other Study ID Numbers: 111722
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009

Keywords provided by GlaxoSmithKline:
expression analysis

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