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: 11 years of FU ] [ 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: 11 years of FU ] [ 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
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||June 2020 (Final data collection date for primary outcome measure)|
Lower-risk MDS patients
Patients with low or intermediate-1 risk MDS according to the International Prognostic Scoring System (IPSS)
Other: No interventions
Only registration of clinical practice
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 seventeen 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 Over 140 hematology centres in seventeen different countries (Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, The Netherlands, Romania, Spain, Sweden and United Kingdom) will participate as referral centres in this Registry. The recruitment target is a minimum of 3000 cases.
The study population will consist of newly diagnosed patients with IPSS low- or intermediate-1 risk myelodysplastic syndrome.
The enrolment time is scheduled to continue until June 2020. Patients will be followed until death or withrawal.
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|