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T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01376674
First received: June 16, 2011
Last updated: June 21, 2011
Last verified: March 2011
History of Changes
  Purpose

Immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner.

In order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. The overall activity of the T-cell-system as well as tumor-specific T-cell-response are evaluated.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes of T-cell-immune-status During Curative Radiotherapy in Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • T-cell-immunity in time-course [ Time Frame: During and 3-6 months after radiotherapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Peripheral blood mononuclear cells and serum are frozen and stored.


Estimated Enrollment: 20
Study Start Date: March 2011
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing standard radiotherapy for localised prostate cancer at the University Hospital of Tuebingen

Criteria

Inclusion Criteria:

  • Localised prostate cancer (node negative)
  • definitive radiotherapy
  • informed consent

Exclusion Criteria:

  • medication including steroids or immunosuppressants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376674

Contacts
Contact: Cihan Gani, MD cihan.gani@med.uni-tuebingen.de

Locations
Germany
Department of Radiation Oncology Recruiting
Tuebingen, Germany, D-72076
Contact: Cihan Gani         cihan.gani@med.uni-tuebingen.de    
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Cihan Gani, M.D. University Hospital Tuebingen
Study Director: Franziska Eckert, MD University Hospital Tuebingen
  More Information

Publications:

Responsible Party: Franziska Eckert M.D., University of Tuebingen
ClinicalTrials.gov Identifier: NCT01376674     History of Changes
Other Study ID Numbers: UKT_RO_01
Study First Received: June 16, 2011
Last Updated: June 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
localised
prostate cancer
radiotherapy
immunology

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013