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NMDS Group

Sponsor: University Medical Center Nijmegen St Radboud for the European LeukemiaNet MDS Working Party.

Principle investigator: Dr David Bowen, Leeds Teaching Hospitals.


Study Title: 
A prospective, multicenter European Registry for newly diagnosed patients with Myelodysplastic Syndromes of IPSS low and intermediate-1 subtypes.

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.

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 in this Registry. The primary recruitment target 1000 pt was reached in January, 2011. The registry is open for inclusion but patients after 1000 are not reimbursed in Sweden. 1000 patients reached in February, 2011.

Inclusion criteria:

  • MDS patients (IPSS Risk group Low or Intermediate-1) provided diagnose within 3 months from inclusion
  • Primary MDS
  • Signed informed consent.

Exclusion criteria:

  • CMML or full-filling criteria for other mixed MDS/MPD disorders excluding RARS-T, which may be included.

This in a non-interventional observation study.

Study Duration: 
The enrollment time will be 18 months. The follow-up period will be 5 years.

Start: 1 April, 2008.

Accrural:  20 patients per 31/10/2008. 1260 patients per 30/06/2012.

Contact person: 
Eva Hellström-Lindberg. Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.