Last updated: 11/03/2018 12:06:06
Analysis of expression of specific markers in hepatocellular carcinoma
GSK study ID
111722
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Analysis of the incidence of expression of a specific set of genes and of tumor antigens in cancer tissue from patients with hepatocellular carcinoma
Trial description: 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. This will be done retrospectively using available hepatocellular carcinoma tissue samples.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
This study will also analyze whether this gene-expression signature is present in matched cirrhotic tissue and the interface tissue with the tumor.
Timeframe: At the time of analysis.
Proportion of hepatocellular carcinoma cancer patients whose tumor tissue -expresses any one or more of specific target antigens -overexpresses c-MET -expresses a pre-defied gene-expression signature
Timeframe: At the time of analysis.
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
30
Primary completion date:
2009-15-12
Observational study model:
Case-Only
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Hepatocellular carcinoma
Product
GSK1711805A
Collaborators
Not applicable
Study date(s)
July 2009 to December 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- The patient had pathologically proven hepatocellular carcinoma
- All the data required are available from patient’s records
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- The patient had pathologically proven hepatocellular carcinoma -All the data required are available from patient’s records -A sufficient amount of RNA is available for all three tissue samples
Exclusion criteria:
- N/A
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2009-15-12
Actual study completion date
2009-15-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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