Last updated: 11/07/2018 02:48:11
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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
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:
Not applicable
Interventions:
Other: Data acquisition and analysis
Enrollment:
377
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Thongprasert S et al. (2016) 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. 101:137-144.
Medical condition
Pathologically proven stage I, II and III Non-Small Cell Lung cancer (NSCLC)
Product
GSK1711805A
Collaborators
Not applicable
Study date(s)
August 2007 to January 2008
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- 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.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
For inclusion of a tissue sample, all of the following criteria must be met:
Exclusion criteria:
- Not applicable
Trial location(s)
Location
GSK Investigational Site
songpa-gu, Seoul, South Korea, 138-736
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2008-31-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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