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Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma
This study has been completed.

First Received on May 28, 2009.   Last Updated on September 29, 2011   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00911196
  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, 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 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 Tumor Antigens and Tumor Marker in Cancer Tissue From Asian Patients With Hepatocellular Carcinoma and Evaluation of Prognostic Significance of These Tumor Antigens.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens. [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • The prognostic character of the expression of the tumor antigens [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]
  • Expression of c-MET in the same hepatocellular carcinoma tumor samples [ Time Frame: At the time of analysis ] [ Designated as safety issue: No ]

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: 200
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911196

Locations
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
Thailand
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Chiangmai, Thailand, 50200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00911196     History of Changes
Other Study ID Numbers: 111726
Study First Received: May 28, 2009
Last Updated: September 29, 2011
Health Authority: Thailand: Maharajnakorn Chiangmai Hospital: Research Ethics Committee, Faculty of Medicine, Chiang Mai University;   Taiwan: Department of Health;   Thailand: Siriraj Hospital: Ethics Committee Faculty of Medicine, Siriraj Hospital, Mahidol University

Keywords provided by GlaxoSmithKline:
Prognosis
Markers
Expression analysis
Hepatocellular carcinoma

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

ClinicalTrials.gov processed this record on February 09, 2012



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