Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.
Study Overview
Brief Summary
This study aims to analyze the incidence of expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME tumor antigens in cancer tissue from patients with pathologically demonstrated bladder cancer.
Detailed Description
There will be no procedure(s) or treatment(s) carried out on patients. All data and samples will be taken from those already stored at the investigation sites. Clinical data collected will include patient demographics (age, gender), Tumor, Node, Metastasis (staging system) [TNM stage], and histopathologic description only. 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For inclusion of a tissue sample, all of the following criteria must be met:
- •The patient had pathologically proven bladder cancer (any stage).
- •All the data required are available from patient's records.
- •There are no restrictions regarding operative technique (cystectomy or cystoscopy).
- •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.
Outcomes
Primary Outcomes
To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.
Time Frame: Up to 1 year
Secondary Outcomes
No secondary outcomes reported