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

Neoplasms, Urinary Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706185
• Other study ID #: 111294
• Status: Completed
• Start date: January 15, 2008
• Est. completion date: January 15, 2008

Study information

• Verified date: July 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 15, 2008
• Est. primary completion date: January 15, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Neoplasms, Urinary Bladder
• Urinary Bladder Neoplasms

Intervention

Other:
• Data acquisition and analysis
Tumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer.

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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