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NCT01837511 Clinical Trial

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

Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01837511
Other study ID # 109937
Secondary ID
Status Completed
Phase N/A
First received April 5, 2013
Last updated April 18, 2013
Start date August 2007
Est. completion date January 2008

Study information
Verified date April 2013
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Taiwan: Taiwan Food and Drug Administration (TFDA)Singapore: Health Sciences AuthorityKorea: Korea Food and Drug Administration (KFDA)Thailand: Thai Food and Drug Administration (TFDA)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 377
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of GSK Investigational Site Seoul
Korea, Republic of GSK Investigational Site songpa-gu, Seoul
Singapore GSK Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Korea, Republic of,  Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
Primary 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. No