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Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01198808
First received: September 8, 2010
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  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:

U.S. FDA Resources

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

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

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

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
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

ClinicalTrials.gov processed this record on May 23, 2013