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A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes (EUMDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Radboud University
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00600860
First received: January 14, 2008
Last updated: November 23, 2016
Last verified: November 2016
  Purpose

Study Objectives:

To collect and describe demographics, disease-management, and treatment outcomes of Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to the WHO criteria.

To perform observational studies concerning relevant scientific research questions in MDS using clinical data and biological samples, and to present relevant research outcomes in the fields of diagnosis and prognostication, health related quality of life issues, health economics, and risk stratification for newly developed classes of drugs.

To disseminate results of the studies to all stakeholders involved.


Condition Intervention
Myelodysplastic Syndromes (MDS)
Other: No interventions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes (MDS), Including Acute Myeloid Leukaemia With 20-30 Percent Marrow Blasts (Former RAEB-t), and Chronic Myelomonocytic Leukaemia (CMML)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Demographics [ Time Frame: 12 years of FU ] [ Designated as safety issue: No ]
    The primary objective of this study is collect and describe demographics, clinical and lab manifestations, epidemiological data, genetic characteristics, HRQoL, disease-management, and treatment outcomes of MDS patients who are newly diagnosed and classified according to the WHO-2008 and WHO-2016 criteria


Secondary Outcome Measures:
  • Correlations [ Time Frame: 12 years of FU ] [ Designated as safety issue: No ]

    To investigate the relationship between:

    • Clinical characteristics at inclusion and during follow-up
    • Treatments received, including transfusions, and
    • Responses to treatment
    • Overall survival
    • Disease progression
    • General and disease specific HRQoL, and Karnofsky Performance Status
    • Health Economics

  • New prognostic scoring systems [ Time Frame: 12 years of FU ] [ Designated as safety issue: No ]
    To derive and validate new prognostic scoring systems

  • Scientific research in MDS [ Time Frame: 12 years of FU ] [ Designated as safety issue: No ]
    To perform observational studies concerning relevant scientific research questions in MDS using clinical data and biological samples and to present relevant research outcomes in the fields of diagnosis & prognostication, HRQoL issues, health economics, risk stratification for newly developed classes of drugs.


Other Outcome Measures:
  • Dissemination [ Time Frame: 12 years of FU ] [ Designated as safety issue: No ]
    To disseminate the results of the studies to all stakeholders involved


Biospecimen Retention:   Samples With DNA
Blood and Bone marrow

Estimated Enrollment: 4000
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
MDS patients
Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification
Other: No interventions
Only registration of clinical practice

Detailed Description:

Methodology:

Data on patients with MDS will be collected prospectively at diagnosis and at 6-months intervals after diagnosis. The data will be gathered by seventeen (or more) countries 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 at the University of York in various sub studies, after every 500 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 (or more) 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 lower-risk MDS and 1000 higher-risk cases.

Population:

The study population will consist of newly diagnosed patients with all subtypes of MDS classified according to the WHO criteria, including therapy-related MDS and MDS-F, AML with 20-30 percent marrow blasts (former RAEB-t), and CMML and other forms of mixed MDS/MPD.

Study Duration:

The enrolment time is scheduled to continue until at least June 2020 but extension of the recruitment period is possible. Patients will be followed until withdrawal (for any reason) or termination of the EUMDS Registry.

  Eligibility

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
Clinic
Criteria

Inclusion Criteria:

Patients must meet all of the following criteria

  • Age > 18 years
  • Newly diagnosed patient (within 100 days from the date of the diagnostic BM aspirate)
  • MDS classified according to current WHO criteria

    • All sub groups of MDS
    • Therapy-related MDS
    • MDS with Fibrosis (MDS-F)
    • AML with 20-30 percent marrow blasts (former RAEB-t)
    • CMML and other forms of mixed MDS/MPD
  • IPSS and IPSS-R Risk group classification (mandatory)
  • Able and willing to provide the written informed consent

Exclusion Criteria:

  • Age <18 years
  • Patient unwilling or unable to give consent
  • AML with ≥30 percent marrow blasts according to WHO
  • Patients with inv(16), t(5;17) and t(8;21) are considered AML and therefore not eligible
  • Patients with higher risk MDS progressed from a previously diagnosed lower risk MDS that was not registered within 100 days after first diagnosis of (lower risk) 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:
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00600860     History of Changes
Other Study ID Numbers: 883 
Study First Received: January 14, 2008
Last Updated: November 23, 2016
Health Authority: Austria: Ethikkommission
Czech Republic: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Romania: Ethics Committee
Spain: Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee
Denmark: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Poland: Ethics Committee
Israel: Ethics Commission
Serbia: Ethics Committee
Croatia: 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 (all IPSS subtypes)
Newly diagnosed

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on December 02, 2016