- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01220427
Micro-RNA Expression Profiles in High Risk Prostate Cancer
March 2, 2016 updated by: Wuerzburg University Hospital
The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Würzburg, Germany, 97080
- Department of Urology and Pediatric Urology University Hospital Würzburg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
University hospital, community hospital
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Clinical high-risk prostate cancer, radical prostatectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recurrence free survival
Time Frame: Yearly update until clinical progression
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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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Yearly update until clinical progression
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
|
Yearly update until death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 12, 2010
First Posted (Estimate)
October 13, 2010
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- mi-RNA HR-Pca
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.