Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma
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.
1 other identifier
observational
200
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 1, 2009
CompletedMay 30, 2017
May 1, 2017
4 months
May 28, 2009
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens.
At the time of analysis
The prognostic character of the expression of the tumor antigens
At the time of analysis
Expression of c-MET in the same hepatocellular carcinoma tumor samples
At the time of analysis
Study Arms (1)
Group A
Interventions
Analysis using RNA extracted from tissue samples already archived; Analysis by Fluorescent in situ hybridization (FISH) using tissue samples already archived.
Eligibility Criteria
Primary care clinic
You may qualify if:
- The patient has pathologically proven hepatocellular carcinoma (any stage)
- All the data required are available from patient's records
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
Biospecimen
This retrospective study is based upon the analysis of archived samples and patient-related data already available at the investigational site
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 1, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 30, 2017
Record last verified: 2017-05