Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes (EUMDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Radboud University
Information provided by (Responsible Party):
Radboud University Identifier:
First received: January 14, 2008
Last updated: February 2, 2016
Last verified: February 2016

Study Objectives:

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.

Condition Intervention
Myelodysplastic Syndromes (MDS)
Other: No interventions

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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
Urine and blood

Estimated Enrollment: 3000
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)
Groups/Cohorts Assigned Interventions
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

Detailed Description:


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.

Study Duration:

The enrolment time is scheduled to continue until June 2020. Patients will be followed until death or withrawal.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Age > 18 years.
  • Newly diagnosed patient (within 3 months from the date of the diagnostic bone marrow aspirate).
  • MDS classified according to WHO criteria (2001).
  • IPSS Risk group Low or Intermediate-1 .
  • Able and willing to provide the written informed consent.

Exclusion Criteria:

  • Age <18 years
  • Patient unwilling or unable to give consent
  • intermediate-2 or high risk MDS, or in case the IPSS group cannot be defined ≥ 5% bone marrow blasts.
  • secondary/therapy-related MDS.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00600860

Contact: Corine J van Marrewijk, PhD +31-24-3614794
Contact: Jackie AH Droste, PhD +31-24-3614794

  Show 17 Study Locations
Sponsors and Collaborators
Radboud University
Study Chair: David Bowen, PhD Leeds General Infirmary
Study Director: Theo de Witte, Prof Dr Radboud University
  More Information

Additional Information:
Responsible Party: Radboud University Identifier: NCT00600860     History of Changes
Other Study ID Numbers: 883 
Study First Received: January 14, 2008
Last Updated: February 2, 2016
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
Croatia: Ethics Committee
Denmark: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Israel: Ethics Commission
Poland: Ethics Committee
Serbia: Ethics Committee
Romania: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The study results (aggregated data) will be published in an academic journal and presented at scientific meetings. A study newsletter will be produced regularly and will be available to read on the EUMDS website.

Keywords provided by Radboud University:
MDS of IPSS low and intermediate-1 subtypes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms processed this record on September 30, 2016