European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes (EUMDS)
To describe the demographics and the disease-management of IPSS low and intermediate-1 Myelodysplastic Syndromes (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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective, Multicenter European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes|
- Demographics [ Time Frame: 2013-2017 ] [ Designated as safety issue: No ]The primary objective of this study is to describe the demographics and the disease-management of newly diagnosed MDS patients within IPSS low and intermediate-1 categories.
- Correlation [ Time Frame: 2017 ] [ Designated as safety issue: No ]
1. To investigate any correlation between:
- Clinical characteristics (including WHO classification and known prognostic factors) at inclusion
- Secondary iron overload due to transfusions
- Treatments received
Biospecimen Retention: Samples With DNA
Urine and blood
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
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 2000.
The study population will consist of newly diagnosed patients with IPSS low- or intermediate-1 risk myelodysplastic syndrome.
The enrollment time i scheduled to be 12 months. Patients will be followed during 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600860
|Contact: Corine J van Marrewijk, PhDfirstname.lastname@example.org|
|Contact: Jackie AH Droste, PhDemail@example.com|
Show 17 Study Locations
|Study Chair:||David Bowen, PhD||Leeds General Infirmary|
|Study Director:||Theo de Witte, Prof Dr||Radboud University|