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

NCT ID: NCT01706185

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-15
• Study Completion Date: 2008-01-15

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.

Conditions

Neoplasms, Urinary Bladder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cancer Group

Data acquisition and analysis

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Leuven, , Belgium

Countries

Belgium

References

Lerut E, Van Poppel H, Joniau S, Gruselle O, Coche T, Therasse P. Rates of MAGE-A3 and PRAME expressing tumors in FFPE tissue specimens from bladder cancer patients: potential targets for antigen-specific cancer immunotherapeutics. Int J Clin Exp Pathol. 2015 Aug 1;8(8):9522-32. eCollection 2015.

Reference Type: DERIVED

PMID: 26464715 (View on PubMed)

Other Identifiers

111294

Identifier Type: -

Identifier Source: org_study_id