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

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.

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Key information

Conditions

Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data acquisition and analysis

Other

Tumor tissue samples submitted with a Patient and Tumor-Sample Characteristics. Form containing previously collected specific clinical data of patients with pathologically proven stage I, II and III NSCLC.

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).

Time frame: 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.

Time frame: Up to 6 months approximately.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Apr 23, 2013
Registry last updated: Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed