Clinical trial NCT01837511: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC)
Keywords: Tumor antigens
Asiatic patients
Reverse Transciptase-Polymerase chain reaction (RT-PCR)
Non-small cell lung cancer (NSCLC)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-04-23
Enrollment: 377
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously collected samples and data of patients with pathologically proven stage I, II and III NSCLC.

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.

Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: Up to 6 months approximately.
measure: 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.
timeFrame: Up to 6 months approximately.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: songpa-gu, Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Thongprasert S, Yang PC, Lee JS, Soo R, Gruselle O, Myo A, Louahed J, Lehmann FF, Brichard VG, Coche T. The prevalence of expression of MAGE-A3 and PRAME tumor antigens in East and South East Asian non-small cell lung cancer patients. Lung Cancer. 2016 Nov;101:137-144. doi: 10.1016/j.lungcan.2016.09.006. Epub 2016 Oct 5.