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Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00858000
First Posted: March 9, 2009
Last Update Posted: December 24, 2009
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.
Information provided by:
GlaxoSmithKline
  Purpose
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 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 a Specific Set of Genes and of Tumor Antigens in Cancer Tissue From Patients With Hepatocellular Carcinoma

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ]
  • 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

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
No intervention
Other: Retrospective analysis of already archived samples
RNA extracted from tissue samples already archived

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00858000


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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00858000     History of Changes
Other Study ID Numbers: 111722
First Submitted: March 5, 2009
First Posted: March 9, 2009
Last Update Posted: December 24, 2009
Last Verified: December 2009

Keywords provided by GlaxoSmithKline:
markers
expression analysis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases