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
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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014