Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer

Trial Information

Analysis of the Incidence of Expression of Tumor Antigens in Cancer Tissue From Patients With Pathologically Demonstrated Bladder Cancer

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.

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

To determine the gene expression of MAGE-A3, MAGE-C2, NY-ESO-1, LAGE-1, WT1 and PRAME antigens in pathologically demonstrated bladder cancer.

Outcome Time Frame:

Up to 1 year

Safety Issue:

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

111294

NCT ID:

NCT01706185

Start Date:

January 2008

Completion Date: