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Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198808
Recruitment Status : Unknown
Verified January 2012 by Technische Universität München.
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2010
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease
Bladder Cancer

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Study Type : Observational
Estimated Enrollment : 50 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Biospecimen Retention:   Samples Without DNA
Peripheral blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198808

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

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Responsible Party: Technische Universität München Identifier: NCT01198808     History of Changes
Other Study ID Numbers: IBT-1
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Technische Universität München:
Bladder cancer
T cells
Tumor-specific immunity in bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases