A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes (EUMDS)
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|ClinicalTrials.gov Identifier: NCT00600860|
Recruitment Status : Recruiting
First Posted : January 25, 2008
Last Update Posted : October 7, 2019
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 or disease||Intervention/treatment|
|Myelodysplastic Syndromes (MDS)||Other: No interventions|
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.
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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)|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification
Other: No interventions
Only registration of clinical practice
- Demographics [ Time Frame: 12 years of FU ]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
- Correlations [ Time Frame: 12 years of FU ]
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 ]To derive and validate new prognostic scoring systems
- Scientific research in MDS [ Time Frame: 12 years of FU ]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.
- Dissemination [ Time Frame: 12 years of FU ]To disseminate the results of the studies to all stakeholders involved
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600860
|Contact: Corine J van Marrewijk, PhDemail@example.com|
|Contact: Rosalie Lubbers, MScfirstname.lastname@example.org|
|Study Chair:||David Bowen, PhD||Leeds General Infirmary|
|Study Director:||Theo de Witte, Prof Dr||Radboud University|