Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer (Sorse)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00668083
First received: April 24, 2008
Last updated: December 9, 2010
Last verified: December 2010
| Tracking Information | |||||
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| First Received Date ICMJE | April 24, 2008 | ||||
| Last Updated Date | December 9, 2010 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hormonal sensitivity to second line treatment for CaP after Bicalutamide [ Time Frame: six months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00668083 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
median duration of second and third line treatments; [ Time Frame: six months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer | ||||
| Official Title ICMJE | Observational Retrospective Trial on Sequential Hormonal Therapy in Patients | ||||
| Brief Summary | Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer |
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| Detailed Description | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Biospecimen | |||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL. |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) | |||||
| Publications * | |||||
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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 | Completed | ||||
| Estimated Enrollment ICMJE | 214 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00668083 | ||||
| Other Study ID Numbers ICMJE | NIS-OIT-CAS-2007/1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Italy: Ethics Committee, AstraZeneca | ||||
| Study Sponsor ICMJE | AstraZeneca | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||
| Verification Date | December 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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