Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

• Conditions: Bladder Cancer

• Registration Number: NCT01198808
• Lead Sponsor: Technical University of Munich

Brief Summary

Bladder cancer is generally susceptible to immunotherapeutic measures. The investigators will characterize 40 patients with muscle-invasive bladder cancer regarding the existence and frequency of tumorspecific T-cells and regulatory T cells. The found data will be correlated to clinical data such as the cancer-specific survival and the response to chemotherapy.

It is hypothesized that those patients with a high number of Tregs and no tumor-specific T-cells have a worse prognosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Histologically confirmed muscle-invasive urothelial carcinoma
• Age > 18 years
• Hemoglobin > 10g/dl
• Signed Informed Consent
• Karnofsky index < 70%

Exclusion Criteria

• Clinically relevant second malignancy
• Severe comorbidities (e.g. NYHA III, end-stage renal disease)
• Chronic infectious disease (HIV, Tuberculosis)
• Immunosupression
• Severe psychiatric diseases
• Blood donation in the last 4 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Urologische Klinik der Technischen Universität München; 🇩🇪 Munich, Bavaria, Germany