Last updated: 11/03/2018 11:30:59

Incidence of expression of tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer

GSK study ID
111294
See study documents
Clinicaltrials.gov ID
NCT01706185
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 in cancer tissue from patients with pathologically demonstrated bladder cancer
Trial description: This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.

Timeframe: Up to 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data acquisition and analysis
    • Enrollment:
    156
    Primary completion date:
    2008-15-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Urinary Bladder
    Product
    GSK1711805A
    Collaborators
    Not applicable
    Study date(s)
    January 2008 to January 2008
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • For inclusion of a tissue sample, all of the following criteria must be met:
    • – The patient had pathologically proven bladder cancer (any stage).
    • Not applicable.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For inclusion of a tissue sample, all of the following criteria must be met: – The patient had pathologically proven bladder cancer (any stage). – All the data required are available from patient's records. There are no restrictions regarding operative technique (cystectomy or cystoscopy). – Many patients may no longer be alive, or no longer be in contact with the investigation sites. Thus, patients will not be required to give their informed consent before inclusion in the study.
    Exclusion criteria:
    • Not applicable.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Leuven, Belgium, 3000
    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
    2008-15-01
    Actual study completion date
    2008-15-01

    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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