Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004066

Trial Description

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Title

Micro-RNA Expression Profiles in High Risk Prostate Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004066
  •   2012/08/02
  •   2010/10/12
  •   yes
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Secondary IDs

  •   NCT01220427  (ClinicalTrials.gov)
  •   mi-RNA HR-Pca  (Wuerzburg University Hospital)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   Radical Prostatectomy
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Recurrence free survival; time frame: Yearly update until clinical progression; 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.

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Secondary Outcome

- Cancer specific survival; time frame: Yearly update until death; 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2007/06/30
  •   300
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Inclusion Criteria

  •   Male
  •   35   Years
  •   80   Years
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Additional Inclusion Criteria

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

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Exclusion Criteria

Non high risk prostate cancer

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Addresses

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    • Wuerzburg University Hospital
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    • Martin H. Spahn, MD 
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    • Martin H. Spahn, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.