the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy
This study is currently recruiting participants.
Verified June 2012 by Tehran University of Medical Sciences
Sponsor:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00497588
First received: July 4, 2007
Last updated: June 2, 2012
Last verified: June 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 4, 2007 | ||||||||
| Last Updated Date | June 2, 2012 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
quality of voice [ Time Frame: 3 to 6 month after therapy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
quality of voice [ Time Frame: 3 to 6 month after therapy ] | ||||||||
| Change History | Complete list of historical versions of study NCT00497588 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
quality of life [ Time Frame: 6 month later ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
quality of life [ Time Frame: 6 month later ] | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | the Comparison of Voice Quality in Early Laryngeal Cancer Between Surgery and Radiotherapy | ||||||||
| Official Title ICMJE | |||||||||
| Brief Summary | early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice ,so we design this trial to answer the priority of each options. |
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| Detailed Description | early laryngeal cancer is a well known field with great controversy in treatment. two options are available in treatment of patients the first one is partial laryngectomy and the second one is radiotherapy.one of major concern of patients have been the quality of voice as part of quality of life ,so we design this clinical randomised trial to answer the priority of each options. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Voice Quality | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 33 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Iran, Islamic Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00497588 | ||||||||
| Other Study ID Numbers ICMJE | bs-86-01-48-5497 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Babak Saedi, Tehran University of Medical Sciences | ||||||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Tehran University of Medical Sciences | ||||||||
| Verification Date | June 2012 | ||||||||
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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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