Last updated: 11/03/2018 12:06:13

Analysis of expression of specific markers and their prognostic significance in hepatocellular carcinoma

GSK study ID
111726
See study documents
Clinicaltrials.gov ID
NCT00911196
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
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, 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The proportion of hepatocellular carcinoma patients whose tumor tissue expresses specific tumor antigens.

Timeframe: At the time of analysis

The prognostic character of the expression of the tumor antigens

Timeframe: At the time of analysis

Expression of c-MET in the same hepatocellular carcinoma tumor samples

Timeframe: At the time of analysis

Secondary outcomes:
Not applicable
Interventions:
  • Other: Retrospective analysis of already archived samples
    • Enrollment:
    200
    Primary completion date:
    2009-18-03
    Observational study model:
    Case-Only
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Hepatocellular carcinoma
    Product
    GSK1711805A
    Collaborators
    Not applicable
    Study date(s)
    November 2008 to March 2009
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • The patient has pathologically proven hepatocellular carcinoma (any stage)
    • All the data required are available from patient’s records
    • N/A
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Taipei, Taiwan, 100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chiangmai, Thailand, 50200
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10700
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2009-18-03
    Actual study completion date
    2009-18-03

    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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