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

Completed

• Conditions: Neoplasms, Urinary Bladder
• Interventions: Other: Data acquisition and analysis

• Registration Number: NCT01706185
• Lead Sponsor: GlaxoSmithKline

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 Timeline

• Study Start: 2008-01-15
• Primary Completion: 2008-01-15
• Study Completion: 2008-01-15
• Study First Submitted: 2012-10-04
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Group	Data acquisition and analysis	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Leuven, Belgium