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

Hepatocellular Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911196
• Other study ID #: 111726
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: May 25, 2017
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patient has pathologically proven hepatocellular carcinoma (any stage)

• All the data required are available from patient's records

Exclusion Criteria:

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens.		At the time of analysis
Primary	The prognostic character of the expression of the tumor antigens		At the time of analysis
Primary	Expression of c-MET in the same hepatocellular carcinoma tumor samples		At the time of analysis