NCT01198808

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

September 8, 2010

Last Update Submit

January 16, 2012

Conditions

Bladder Cancer

Keywords

Bladder cancerchemotherapyT cellsImmunotherapyTumor-specific immunity in bladder cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Histologically confirmed muscle-invasive urothelial carcinoma
  • Age \> 18 years
  • Hemoglobin \> 10g/dl
  • Signed Informed Consent
  • Karnofsky index \< 70%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urologische Klinik der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Thomas Horn, MD

    Department of Urology, Technische Universität München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2011

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

DE(1)