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Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Technische Universität München.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01198808
First Posted: September 10, 2010
Last Update Posted: January 18, 2012
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.
Information provided by (Responsible Party):
Technische Universität München
  Purpose

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
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01198808


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

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01198808     History of Changes
Other Study ID Numbers: IBT-1
First Submitted: September 8, 2010
First Posted: September 10, 2010
Last Update Posted: January 18, 2012
Last Verified: January 2012

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

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