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

July 27, 2018 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously collected samples and data of patients with pathologically demonstrated bladder cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2008

Primary Completion (Actual)

January 15, 2008

Study Completion (Actual)

January 15, 2008

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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