Analysis of Expression of Specific Markers and Their Prognostic Significance in Hepatocellular Carcinoma
May 25, 2017 updated by: GlaxoSmithKline
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Primary care clinic
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
|
Analysis using RNA extracted from tissue samples already archived; Analysis by Fluorescent in situ hybridization (FISH) using tissue samples already archived.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens.
Time Frame: At the time of analysis
|
At the time of analysis
|
|
The prognostic character of the expression of the tumor antigens
Time Frame: At the time of analysis
|
At the time of analysis
|
|
Expression of c-MET in the same hepatocellular carcinoma tumor samples
Time Frame: At the time of analysis
|
At the time of analysis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 28, 2009
First Submitted That Met QC Criteria
May 28, 2009
First Posted (Estimate)
June 1, 2009
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 25, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111726
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.