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| Tracking Information | |||||||||
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| First Received Date † | January 14, 2008 | ||||||||
| Last Updated Date | May 11, 2009 | ||||||||
| Start Date † | April 2008 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00600860 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes | ||||||||
| Official Title † | A Prospective, Multicenter European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes | ||||||||
| Brief Summary | Study Objectives: To describe the demographics and the disease-management of IPSS low and intermediate-1 MDS patients who are newly diagnosed and classified according to the WHO criteria. To collect and to present data on clinical characteristics, disease-management and relevant outcomes. |
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| Detailed Description | Methodology: Data on patients with low or intermediate-1 risk MDS will be collected prospectively at diagnosis and at 6-months intervals after diagnosis. The data will be gathered by eleven existing national MDS Registries that are represented within the LeukemiaNet MDS Working Party and will be combined in one central European Database. Data analyses will be conducted by the Data Management Centre after every 400 patients included in the European Registry and at the end of the follow-up period. Number of Patients & Centres Eleven hematology centres in eleven different countries (Austria, Czech Republic, France, Germany, Greece, Italy, Netherlands, Rumania, Spain, Sweden and United Kingdom) will participate as referral centres in this Registry. The recruitment target is 1000. Population: The study population will consist of newly diagnosed patients with IPSS low- or intermediate-1 risk myelodysplastic syndrome. Study Duration: The enrollment time will be 12 months. The follow-up period will be 2 years. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Cohort, Prospective | ||||||||
| Condition † | Myelodysplastic Syndromes | ||||||||
| Intervention † | |||||||||
| Study Arms / Comparison Groups | |||||||||
| 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 † | Recruiting | ||||||||
| Estimated Enrollment † | 1000 | ||||||||
| Estimated Completion Date | March 2011 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Austria, Czech Republic, France, Germany, Greece, Italy, Netherlands, Romania, Spain, Sweden, United Kingdom | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00600860 | ||||||||
| Responsible Party | Prof Dr de Witte, Radboud University Nijmegen Medical Centre | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Radboud University | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Radboud University | ||||||||
| Verification Date | May 2009 | ||||||||
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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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