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 March 2014 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00600860
First received: January 14, 2008
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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
Myelodysplastic Syndromes

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: 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 2000
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)
Detailed Description:

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 2000.

Population:

The study population will consist of newly diagnosed patients with IPSS low- or intermediate-1 risk myelodysplastic syndrome.

Study Duration:

The enrollment time i scheduled to be 12 months. Patients will be followed during 4 years.

  Eligibility

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

Clinic

Criteria

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 ClinicalTrials.gov identifier: NCT00600860

Contacts
Contact: Corine J van Marrewijk, PhD +31-24-3614794 corine.vanmarrewijk@radboudumc.nl
Contact: Jackie AH Droste, PhD +31-24-3614794 jackie.droste@radboudumc.nl

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

Additional Information:
No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00600860     History of Changes
Other Study ID Numbers: 883
Study First Received: January 14, 2008
Last Updated: March 21, 2014
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

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014