Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

Bladder Cancer Clinical Trial

Official title:

Prospective Characterization of Tumor-specific T-cell Immunity in Muscle-invasive Bladder Cancer and Its Correlation With Clinical Parameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01198808
• Other study ID #: IBT-1
• Status: Active, not recruiting
• Phase: N/A
• First received: September 8, 2010
• Last updated: January 16, 2012
• Start date: August 2010

Study information

• Verified date: January 2012
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Local ethics commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Germany	Urologische Klinik der Technischen Universität München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany,