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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00911196
• Collaborator: (none)
• Enrollment: 200
• Locations: 3
• Duration (Months): 3.9
• Patients Per Site: 66.7
• Patients Per Site Per Month: 16.9

Study Details

Study Description

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, 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Other: Retrospective analysis of already archived samples

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• 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.
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Group A	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.

Outcome Measures

Primary Outcome Measures

1. The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens. [At the time of analysis]

2. The prognostic character of the expression of the tumor antigens [At the time of analysis]

3. Expression of c-MET in the same hepatocellular carcinoma tumor samples [At the time of analysis]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

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

Exclusion Criteria:

N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Taipei		Taiwan	100
2	GSK Investigational Site	Bangkok		Thailand	10700
3	GSK Investigational Site	Chiangmai		Thailand	50200

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00911196
• Other Study ID Numbers: 111726
• First Posted: Jun 1, 2009
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 2017

• Keywords provided by GlaxoSmithKline: Prognosis; Markers; Expression analysis; Hepatocellular carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 30, 2017