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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


N/A
N/A
N/A
Not Enrolling
Both
Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC)

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Trial Information

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


This study will be based upon the analysis of samples and patient-related data already
available at the various investigation sites. There will be no study treatment and no
study-specific procedure carried out on the patients.

Clinical data collected will include patient demographics (age, gender), Tumor, Node,
Metastasis (staging system) [TNM stage], histopathologic description and the patient smoker
status. Strict anonymity of patient data will be maintained.

This retrospective study is based upon the analysis of archived formalin-fixed
paraffin-embedded tissue samples and patient-related data already available at the
investigational site.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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).

Outcome Time Frame:

Up to 6 months approximately.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Taiwan: Taiwan Food and Drug Administration (TFDA)

Study ID:

109937

NCT ID:

NCT01837511

Start Date:

August 2007

Completion Date:

January 2008

Related Keywords:

  • Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC)
  • Tumor antigens
  • Asiatic patients
  • Reverse Transciptase-Polymerase chain reaction (RT-PCR)
  • Non-small cell lung cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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