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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01837511
Collaborator
(none)
377
3
5
125.7
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Data acquisition and analysis

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 Design

Study Type:
Observational
Actual Enrollment :
377 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Cancer Group

Patients with pathologically proven stage I, II and III NSCLC.

Other: Data acquisition and analysis
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.

Outcome Measures

Primary Outcome Measures

  1. 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.]

  2. 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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Seoul Korea, Republic of 137-701
2 GSK Investigational Site songpa-gu, Seoul Korea, Republic of 138-736
3 GSK Investigational Site Singapore Singapore 169608

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01837511
Other Study ID Numbers:
  • 109937
First Posted:
Apr 23, 2013
Last Update Posted:
Apr 23, 2013
Last Verified:
Apr 1, 2013

Study Results

No Results Posted as of Apr 23, 2013