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
Recruitment status was Recruiting
Sponsor:
Wuerzburg University Hospital
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 12, 2010 | ||||
| Last Updated Date | October 12, 2010 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Micro-RNA Expression Profiles in High Risk Prostate Cancer | ||||
| Official Title ICMJE | Micro-RNA Expression Profiles in High Risk Prostate Cancer | ||||
| Brief Summary | The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | University hospital, community hospital |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Clinical high-risk prostate cancer, radical prostatectomy | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Male | ||||
| Ages | 35 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01220427 | ||||
| Other Study ID Numbers ICMJE | mi-RNA HR-Pca | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Martin Spahn, University Hospital Würzburg | ||||
| Study Sponsor ICMJE | Wuerzburg University Hospital | ||||
| Collaborators ICMJE | Universitaire Ziekenhuizen Leuven | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Wuerzburg University Hospital | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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