- ICH GCP
- US Clinical Trials Registry
- 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
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 Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 137-701
- GSK Investigational Site
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songpa-gu, Seoul, Korea, Republic of, 138-736
- GSK Investigational Site
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Singapore, Singapore, 169608
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cancer Group
Patients with pathologically proven stage I, II and III NSCLC.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
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Up to 6 months approximately.
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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.
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Up to 6 months approximately.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 109937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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