Tumorspecific T-cell Immunity in Bladder Cancer as Prognostic Marker

NCT ID: NCT01198808

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Horn, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Technische Universität München

Locations

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Urologische Klinik der Technischen Universität München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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IBT-1

Identifier Type: -

Identifier Source: org_study_id

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