Analysis of Expression of Specific Markers in Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858000
• Other study ID #: 111722
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: December 23, 2009
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Retrospective analysis of already archived samples
RNA extracted from tissue samples already archived

Locations

Country	Name	City	State
Italy	GSK Investigational Site	Firenze	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor.		At the time of analysis.	No
Primary	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		At the time of analysis.	No