Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease
This study has been terminated.
(Study stopped because of disappointing inclusion rates)
Sponsor:
Catharina Ziekenhuis Eindhoven
Collaborator:
Erasmus Medical Center
Information provided by:
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT00472706
First received: May 10, 2007
Last updated: May 12, 2010
Last verified: May 2010
| Tracking Information | |||||
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| First Received Date ICMJE | May 10, 2007 | ||||
| Last Updated Date | May 12, 2010 | ||||
| Start Date ICMJE | May 2007 | ||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
recurrence rate [ Time Frame: two years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
recurrence rate [ Time Frame: two years ] | ||||
| Change History | Complete list of historical versions of study NCT00472706 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
cosmetic outcome [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
cosmetic outcome [ Time Frame: one year ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease | ||||
| Official Title ICMJE | A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease | ||||
| Brief Summary | The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy. |
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| Detailed Description | The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Bowen's Disease | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | Terminated | ||||
| Enrollment ICMJE | 65 | ||||
| Completion Date | February 2010 | ||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00472706 | ||||
| Other Study ID Numbers ICMJE | M06-16107 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Drs. A. Verzijl, Catharina hospital/Erasmus MC | ||||
| Study Sponsor ICMJE | Catharina Ziekenhuis Eindhoven | ||||
| Collaborators ICMJE | Erasmus Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | Catharina Ziekenhuis Eindhoven | ||||
| Verification Date | May 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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