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Micro-RNA Expression Profiles in High Risk Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Wuerzburg University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by:
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01220427
First received: October 12, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.


Condition
Prostate Cancer
Radical Prostatectomy

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Micro-RNA Expression Profiles in High Risk Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Recurrence free survival [ Time Frame: Yearly update until clinical progression ] [ Designated as safety issue: No ]
    The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death.


Secondary Outcome Measures:
  • Cancer specific survival [ Time Frame: Yearly update until death ] [ Designated as safety issue: No ]
    The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly until death.


Estimated Enrollment: 300
Study Start Date: June 2007
Groups/Cohorts
Clinical high-risk prostate cancer, radical prostatectomy

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

University hospital, community hospital

Criteria

Inclusion Criteria:

Patients with clinically localised high risk prostate cancer (cT>2, bx GS >7, PSA >20 ng/ml) scheduled for radical prostatectomy.

Exclusion Criteria:

Non high risk prostate cancer

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220427

Contacts
Contact: Martin H. Spahn, MD 0049931201 ext 32025 spahn_m@klinik.uni-wuerzburg.de

Locations
Germany
Department of Urology and Pediatric Urology University Hospital Würzburg Recruiting
Würzburg, Germany, 97080
Contact: martin spahn     ++4993120132025     spahn_m@klinik.uni-wuerzburg.de    
Sponsors and Collaborators
Wuerzburg University Hospital
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Martin Spahn, University Hospital Würzburg
ClinicalTrials.gov Identifier: NCT01220427     History of Changes
Other Study ID Numbers: mi-RNA HR-Pca
Study First Received: October 12, 2010
Last Updated: October 12, 2010
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Wuerzburg University Hospital:
high-risk prostate cancer
radical prostatectomy
micro-RNA

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 16, 2013