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

Completed

• Conditions: Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC)
• Interventions: Other: Data acquisition and analysis

• Registration Number: NCT01837511
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2013-04
• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-18
• Last Update Submitted: 2013-04-18
• Study First Posted: 2013-04-23
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Group	Data acquisition and analysis	Patients with pathologically proven stage I, II and III NSCLC.

Primary Outcome Measures

Name	Time	Method
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).	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.	Up to 6 months approximately.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore