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
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters
Biospecimen Retention: Samples Without DNA
| Estimated Enrollment:
| Study Start Date:
| 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:
|Accepts Healthy Volunteers:
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
- Histologically confirmed muscle-invasive urothelial carcinoma
- Age > 18 years
- Hemoglobin > 10g/dl
- Signed Informed Consent
- Karnofsky index < 70%
- Clinically relevant second malignancy
- Severe comorbidities (e.g. NYHA III, end-stage renal disease)
- Chronic infectious disease (HIV, Tuberculosis)
- Severe psychiatric diseases
- Blood donation in the last 4 weeks
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
|Urologische Klinik der Technischen Universität München
|Munich, Bavaria, Germany, 81675 |
Technische Universität München
||Thomas Horn, MD
||Department of Urology, Technische Universität München
No publications provided
||Technische Universität München
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2010
||January 16, 2012
||Germany: Local ethics commission
Keywords provided by Technische Universität München:
Tumor-specific immunity in bladder cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases