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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

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ClinicalTrials.gov Identifier: NCT01837511
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC) 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.

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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 : August 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Group/Cohort 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.




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). [ Time Frame: 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. [ Time Frame: Up to 6 months approximately. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously collected samples and data of patients with pathologically proven stage I, II and III NSCLC.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837511


Locations
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Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
songpa-gu, Seoul, Korea, Republic of, 138-736
Singapore
GSK Investigational Site
Singapore, Singapore, 169608
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01837511    
Other Study ID Numbers: 109937
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by GlaxoSmithKline:
Tumor antigens
Asiatic patients
Reverse Transciptase-Polymerase chain reaction (RT-PCR)
Non-small cell lung cancer (NSCLC)
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms