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

This study is currently recruiting participants.
Verified by Radboud University, June 2008

Sponsors and Collaborators: Radboud University
University of York
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00600860
  Purpose

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.


Condition
Myelodysplastic Syndromes

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   A Prospective, Multicenter European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes

Further study details as provided by Radboud University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Urine and blood


Estimated Enrollment:   1000
Study Start Date:   April 2008
Estimated Study Completion Date:   March 2011

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 1000.

Population:

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

Study Duration:

The enrollment time will be 12 months. The follow-up period will be 2 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600860

Contacts
Contact: Jackie AH Droste, PhD     +31-24-3614794     j.droste@hemat.umcn.nl    

Locations
Austria
University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology     Recruiting
      Innsbruck, Austria
Czech Republic
Institute of Haematology and Blood Transfusion U nemocnice     Recruiting
      Prague, Czech Republic
France
Hopital Avicenne Universite Paris, Dept of Hematology     Recruiting
      Paris, France
Germany
Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie     Recruiting
      Dusseldorf, Germany
Greece
University of Patras Medical School, Haematology Division, Dept of Internal Medicine     Recruiting
      Patras, Greece
Italy
University of Pavia Medical SChool, Dept of Hematology     Not yet recruiting
      Pavia, Italy
Netherlands
Radboud University Nijmegen Medical Centre, dept of Hematology     Recruiting
      Nijmegen, Netherlands
Romania
Fundeni CLinical Institute, Clinic of Hematology     Recruiting
      Bucharest, Romania
Spain
Hospital La Fe, Dept of Hematology     Not yet recruiting
      Valencia, Spain
Sweden
Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology     Recruiting
      Stockholm, Sweden
United Kingdom
Leeds General Infirmary Dept of Hematology     Not yet recruiting
      Leeds, United Kingdom

Sponsors and Collaborators
Radboud University
University of York

Investigators
Study Chair:     David Bowen, PhD     Leeds General Infirmary    
Study Director:     Theo de WItte, Prof Dr     Radboud University    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Radboud University Nijmegen Medical Centre ( Prof Dr de Witte )
Study ID Numbers:   883
First Received:   January 14, 2008
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00600860
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

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

Study placed in the following topic categories:
Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 28, 2008




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