Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Technische Universität München.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
First received: September 8, 2010
Last updated: January 16, 2012
Last verified: January 2012

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.

Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Biospecimen Retention:   Samples Without DNA

Peripheral blood

Estimated Enrollment: 50
Study Start Date: August 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The study population will consist of patients with muscle-invasive bladder cancer, who are referred to the university hospital: Krankenhaus rechts der Isar der Technischen Universität München


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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01198808

Urologische Klinik der Technischen Universität München
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Thomas Horn, MD Department of Urology, Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01198808     History of Changes
Other Study ID Numbers: IBT-1
Study First Received: September 8, 2010
Last Updated: January 16, 2012
Health Authority: Germany: Local ethics commission

Keywords provided by Technische Universität München:
Bladder cancer
T cells
Tumor-specific immunity in bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 08, 2015