EUMDS: A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
Study Details
Study Description
Brief Summary
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 World Health Organization (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 | Phase |
|---|---|---|
|
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, at specific time points as decided or requested by the steering committee, but at least once a year included in the European Registry and at the end of the follow-up period.
Number of Patients & Centres Over 149 hematology centres in eighteen (or more) different countries (Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, The Netherlands, Romania, Spain, Sweden, Switzerland 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 December 2022 but extension of the recruitment period is possible. Patients will be followed until withdrawal (for any reason) or termination of the EUMDS Registry.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Demographics [14.5 years of follow-up (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
Secondary Outcome Measures
- Correlations [14.5 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 [14.5 years of FU]
To derive and validate new prognostic scoring systems
- Scientific research in MDS [14.5 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.
Other Outcome Measures
- Dissemination [14.5 years of FU]
To disseminate the results of the studies to all stakeholders involved
Eligibility Criteria
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 bone marrow (BM) aspirate)
-
MDS classified according to current WHO criteria
-
All sub groups of MDS
-
Therapy-related MDS
-
MDS with Fibrosis (MDS-F)
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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)
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Able and willing to provide the written informed consent
Exclusion Criteria:
-
Age <18 years
-
Patient unwilling or unable to give consent
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AML with ≥30 percent marrow blasts according to WHO
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology | Innsbruck | Austria | ||
| 2 | Clinical Hospital Merkur | Zagreb | Croatia | ||
| 3 | Institute of Haematology and Blood Transfusion U nemocnice | Prague | Czechia | ||
| 4 | Aarhus University Hospital | Aarhus | Denmark | ||
| 5 | Hopital Avicenne Universite Paris, Dept of Hematology | Paris | France | ||
| 6 | Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie | Dusseldorf | Germany | ||
| 7 | University of Patras Medical School, Haematology Division, Dept of Internal Medicine | Patras | Greece | ||
| 8 | Tel-Aviv Sourasky Medical Center, Dept. of Medicine A | Tel-Aviv | Israel | ||
| 9 | University of Pavia Medical SChool, Dept of Hematology | Pavia | Italy | ||
| 10 | Radboud University Nijmegen Medical Centre, dept of Hematology | Nijmegen | Netherlands | ||
| 11 | Medical University, Dept of Hematology, Oncology and Internal Medicine | Warszawa | Poland | ||
| 12 | Instituto Português de Oncologia de Lisboa, | Lisbon | Portugal | ||
| 13 | Fundeni CLinical Institute, Clinic of Hematology | Bucharest | Romania | ||
| 14 | Clinical Center of Vojvodina | Novi Sad | Serbia | ||
| 15 | Hospital La Fe, Dept of Hematology | Valencia | Spain | ||
| 16 | Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology | Stockholm | Sweden | ||
| 17 | Inselspital | Bern | Switzerland | ||
| 18 | Leeds General Infirmary Dept of Hematology | Leeds | United Kingdom |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
- Study Chair: David Bowen, PhD, Leeds General Infirmary
- Study Director: Theo de Witte, Prof Dr, Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- European MDS Registry
- European MDS network platform
- Publication (PMID: 25907546): Validation of the revised international prognostic scoring system (IPSS-R) in patients with lower-risk myelodysplastic syndromes: a report from the prospective European LeukaemiaNet MDS (EUMDS) registry
- Publication (PMID: 27926979): Erythropoiesis-stimulating agents significantly delay the onset of a regular transfusion need in nontransfused patients with lower-risk myelodysplastic syndrome
- Publication (PMID: 28526957): Cytomorphology review of 100 newly diagnosed lower-risk MDS patients in the European LeukemiaNet MDS (EUMDS) registry reveals a high inter-observer concordance
- Publication (PMID: 29122992): Labile plasma iron levels predict survival in patients with lower-risk myelodysplastic syndromes
- Publication (PMID: 29407183): Prognostic impact of a suboptimal number of analyzed metaphases in normal karyotype lower-risk MDS
- Publication (PMID: 29572506): Health-related quality of life in lower-risk MDS patients compared with age- and sex-matched reference populations: a European LeukemiaNet study
- Publication (PMID: 30126931): Early platelet count kinetics has prognostic value in lower-risk MDS
- Publication (PMID: 31171638): Impact of red blood cell transfusion dose density on progression-free survival in lower-risk myelodysplastic syndromes patients
- Publication (PMID: 31278207): Impact of treatment with iron chelation therapy in patients with lower-risk myelodysplastic syndromes participating in the European MDS registry
- Publication (PMID: 30037803): The use of immunosuppressive therapy in MDS: clinical outcomes and their predictors in a large international patient cohort
Publications
None provided.- 883