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Sponsors and Collaborators: |
Radboud University University of York |
Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00600860 |
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.
Condition |
Myelodysplastic Syndromes |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Prospective, Multicenter European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes |
Urine and blood
Estimated Enrollment: | 1000 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Clinic
Inclusion Criteria:
Exclusion Criteria:
Contact: Jackie AH Droste, PhD | +31-24-3614794 | j.droste@hemat.umcn.nl |
Austria | |||||
University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology | Recruiting | ||||
Innsbruck, Austria | |||||
Czech Republic | |||||
Institute of Haematology and Blood Transfusion U nemocnice | Recruiting | ||||
Prague, Czech Republic | |||||
France | |||||
Hopital Avicenne Universite Paris, Dept of Hematology | Recruiting | ||||
Paris, France | |||||
Germany | |||||
Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie | Recruiting | ||||
Dusseldorf, Germany | |||||
Greece | |||||
University of Patras Medical School, Haematology Division, Dept of Internal Medicine | Recruiting | ||||
Patras, Greece | |||||
Italy | |||||
University of Pavia Medical SChool, Dept of Hematology | Not yet recruiting | ||||
Pavia, Italy | |||||
Netherlands | |||||
Radboud University Nijmegen Medical Centre, dept of Hematology | Recruiting | ||||
Nijmegen, Netherlands | |||||
Romania | |||||
Fundeni CLinical Institute, Clinic of Hematology | Recruiting | ||||
Bucharest, Romania | |||||
Spain | |||||
Hospital La Fe, Dept of Hematology | Not yet recruiting | ||||
Valencia, Spain | |||||
Sweden | |||||
Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology | Recruiting | ||||
Stockholm, Sweden | |||||
United Kingdom | |||||
Leeds General Infirmary Dept of Hematology | Not yet recruiting | ||||
Leeds, United Kingdom |
Radboud University |
University of York |
Study Chair: | David Bowen, PhD | Leeds General Infirmary |
Study Director: | Theo de WItte, Prof Dr | Radboud University |
Related Info 
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Responsible Party: | Radboud University Nijmegen Medical Centre ( Prof Dr de Witte ) |
Study ID Numbers: | 883 |
First Received: | January 14, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00600860 |
Health Authority: | Austria: Ethikkommission; Czech Republic: Ethics Committee; France: Institutional Ethical Committee; Germany: Ethics Commission; Greece: Ethics Committee; Spain: Ethics Committee; Italy: Ethics Committee; United Kingdom: Research Ethics Committee; Sweden: Regional Ethical Review Board |
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