This trial is active, not recruiting.

Condition bladder cancer
Sponsor Technische Universität München
Start date August 2010
End date December 2011
Trial size 50 participants
Trial identifier NCT01198808, IBT-1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters
Principal investigator Thomas Horn, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Technische Universität München.