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| Tracking Information | |||||||||
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| First Received Date † | December 4, 2007 | ||||||||
| Last Updated Date | December 4, 2007 | ||||||||
| Start Date † | January 2008 | ||||||||
| Current Primary Outcome Measures † |
Documentation of side effects [ Time Frame: 3 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Evaluation of Side Effects of Mitotane | ||||||||
| Official Title † | Evaluierung Von Nebenwirkungen Einer Therapie Mit Mitotane Beim Nebennierenkarzinom- Evaluation of Side Effects of Mitotane in Adrenocortical Carcinoma | ||||||||
| Brief Summary | Mitotane is standard therapy in the treatment of adrenocortical carcinoma. However, many side effects are not well documented. Therefore, we are aiming at collecting data about side effects in patients treated with mitotane |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Case Control, Prospective | ||||||||
| Condition † | Adrenocortical Carcinoma | ||||||||
| Intervention † | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 200 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Germany | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00568139 | ||||||||
| Responsible Party | Martin Fassnacht, University of Wuerzburg | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Wuerzburg | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of Wuerzburg | ||||||||
| Verification Date | December 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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