Last updated: 11/07/2018 02:48:11

Analysis of the incidence of expression of tumor antigens in pathologically proven stage I, II and III Non-Small Cell Lung cancer(NSCLC) in Asiatic patients

GSK study ID
109937
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Clinicaltrials.gov ID
NCT01837511
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 MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME in pathologically proven stage I, II and III Non-Small Cell Lung cancer in Asiatic patients
Trial description: This study aims to investigate the expression of Melanoma-associated antigen 3 (MAGE-A3), Melanoma-associated antigen C2 (MAGE-C2), New York esophageal squamous cell carcinoma 1 (NY-ESO-1), L antigen family member 1 (LAGE-1), Wilms’ tumor gene (WT1) and PRAME (PReferentially expressed Antigen of MElanoma) tumor antigens in a large number of pathologically proven stage I, II and III NSCLC samples of Asiatic patients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Determination of the expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in tumor tissue from Asiatic patients with pathologically proven stage I, II or III NSCLC (as defined by the International Staging System).

Timeframe: Up to 6 months approximately.

Determination ofthe correlation of expression levels and co-expression patterns as detected by immunohistochemistry (IHC; protein expression) and as detected by RT-PCR (gene expression) for tumor antigens for which specific antibodies are available.

Timeframe: Up to 6 months approximately.

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data acquisition and analysis
    • Enrollment:
    377
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Thongprasert S et al. (2016) The prevalence of expression of MAGE-A3 and PRAME tumor antigens in East and South East Asian non-small cell lung cancer patients. Lung Cancer. 101:137-144.
    Medical condition
    Pathologically proven stage I, II and III Non-Small Cell Lung cancer (NSCLC)
    Product
    GSK1711805A
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to January 2008
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • For inclusion of a tissue sample, all of the following criteria must be met:
    • The patient had pathologically proven stage I, II or III NSCLC.
    • 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 stage I, II or III NSCLC.
      • All the data required are available from patient’s records.
      • 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
    Singapore, Singapore, 169608
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 137-701
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    songpa-gu, Seoul, South Korea, 138-736
    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
    Not applicable
    Actual study completion date
    2008-31-01

    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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