A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
NCT ID: NCT00600860
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4000 participants
OBSERVATIONAL
2008-04-30
2023-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MDS patients
Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification
No interventions
Only registration of clinical practice
Interventions
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No interventions
Only registration of clinical practice
Eligibility Criteria
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Inclusion 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)
* 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
* 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
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Bowen, PhD
Role: STUDY_CHAIR
Leeds General Infirmary
Theo de Witte, Prof Dr
Role: STUDY_DIRECTOR
Radboud University Medical Center
Locations
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University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology
Innsbruck, , Austria
Clinical Hospital Merkur
Zagreb, , Croatia
Institute of Haematology and Blood Transfusion U nemocnice
Prague, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Hopital Avicenne Universite Paris, Dept of Hematology
Paris, , France
Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie
Düsseldorf, , Germany
University of Patras Medical School, Haematology Division, Dept of Internal Medicine
Pátrai, , Greece
Tel-Aviv Sourasky Medical Center, Dept. of Medicine A
Tel Aviv, , Israel
University of Pavia Medical SChool, Dept of Hematology
Pavia, , Italy
Radboud University Nijmegen Medical Centre, dept of Hematology
Nijmegen, , Netherlands
Medical University, Dept of Hematology, Oncology and Internal Medicine
Warsaw, , Poland
Instituto Português de Oncologia de Lisboa,
Lisbon, , Portugal
Fundeni CLinical Institute, Clinic of Hematology
Bucharest, , Romania
Clinical Center of Vojvodina
Novi Sad, , Serbia
Hospital La Fe, Dept of Hematology
Valencia, , Spain
Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology
Stockholm, , Sweden
Inselspital
Bern, , Switzerland
Leeds General Infirmary Dept of Hematology
Leeds, , United Kingdom
Countries
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Central Contacts
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References
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Garelius HKG, Bagguley T, Taylor A, Fenaux P, Bowen D, Symeonidis A, Mittelmann M, Stauder R, Cermak J, Sanz G, Langemeijer S, Malcovati L, Germing U, Sanhes L, d'Aveni M, Culligan D, Kotsianidis I, Koinig KA, van Marrewijk C, Crouch S, deWitte T, Smith A, Hellstrom-Lindberg E. Survival and quality of life in patients with lower risk myelodysplastic syndromes exposed to erythropoiesis-stimulating agents: an observational cohort study. Lancet Haematol. 2025 Feb;12(2):e128-e137. doi: 10.1016/S2352-3026(24)00350-8.
Rombaut D, Sandmann S, Tekath T, Crouch S, de Graaf AO, Smith A, Painter D, Kosmider O, Tobiasson M, Lennartsson A, van der Reijden BA, Park S, D'Aveni M, Slama B, Clappier E, Fenaux P, Ades L, van de Loosdrecht A, Langemeijer S, Symeonidis A, Cermak J, Preudhomme C, Savic A, Germing U, Stauder R, Bowen D, van Marrewijk C, Bernard E, de Witte T, Varghese J, Hellstrom-Lindberg E, Dugas M, Martens J, Malcovati L, Jansen JH, Fontenay M; MDS-RIGHT consortium. Somatic mutations and DNA methylation identify a subgroup of poor prognosis within lower-risk myelodysplastic syndromes. Hemasphere. 2025 Jan 22;9(1):e70073. doi: 10.1002/hem3.70073. eCollection 2025 Jan.
Stojkov I, Conrads-Frank A, Rochau U, Arvandi M, Koinig KA, Schomaker M, Mittelman M, Fenaux P, Bowen D, Sanz GF, Malcovati L, Langemeijer S, Germing U, Madry K, Guerci-Bresler A, Culligan DJ, Kotsianidis I, Sanhes L, Mills J, Puntscher S, Schmid D, van Marrewijk C, Smith A, Efficace F, de Witte T, Stauder R, Siebert U. Determinants of low health-related quality of life in patients with myelodysplastic syndromes: EUMDS Registry study. Blood Adv. 2023 Jun 27;7(12):2772-2783. doi: 10.1182/bloodadvances.2022008360.
de Swart L, Crouch S, Hoeks M, Smith A, Langemeijer S, Fenaux P, Symeonidis A, Cermak J, Hellstrom-Lindberg E, Stauder R, Sanz G, Mittelman M, Holm MS, Malcovati L, Madry K, Germing U, Tatic A, Savic A, Almeida AM, Gredelj-Simec N, Guerci-Bresler A, Beyne-Rauzy O, Culligan D, Kotsianidis I, Itzykson R, van Marrewijk C, Blijlevens N, Bowen D, de Witte T; EUMDS Registry Participants. Impact of red blood cell transfusion dose density on progression-free survival in patients with lower-risk myelodysplastic syndromes. Haematologica. 2020 Mar;105(3):632-639. doi: 10.3324/haematol.2018.212217. Epub 2019 Jun 6.
Itzykson R, Crouch S, Travaglino E, Smith A, Symeonidis A, Hellstrom-Lindberg E, Sanz G, Cermak J, Stauder R, Elena C, Germing U, Mittelman M, Langemeijer S, Madry K, Tatic A, Holm MS, Almeida AM, Savic A, Simec NG, Luno E, Culligan D, Guerci-Bresler A, Malcovati L, van Marrewijk C, Bowen D, de Witte T, Fenaux P; European MDS Registry members. Early platelet count kinetics has prognostic value in lower-risk myelodysplastic syndromes. Blood Adv. 2018 Aug 28;2(16):2079-2089. doi: 10.1182/bloodadvances.2018020495.
de Swart L, Reiniers C, Bagguley T, van Marrewijk C, Bowen D, Hellstrom-Lindberg E, Tatic A, Symeonidis A, Huls G, Cermak J, van de Loosdrecht AA, Garelius H, Culligan D, Macheta M, Spanoudakis M, Panagiotidis P, Krejci M, Blijlevens N, Langemeijer S, Droste J, Swinkels DW, Smith A, de Witte T; EUMDS Steering Committee. Labile plasma iron levels predict survival in patients with lower-risk myelodysplastic syndromes. Haematologica. 2018 Jan;103(1):69-79. doi: 10.3324/haematol.2017.171884. Epub 2017 Nov 9.
Garelius HK, Johnston WT, Smith AG, Park S, de Swart L, Fenaux P, Symeonidis A, Sanz G, Cermak J, Stauder R, Malcovati L, Mittelman M, van de Loosdrecht AA, van Marrewijk CJ, Bowen D, Crouch S, de Witte TJ, Hellstrom-Lindberg E. Erythropoiesis-stimulating agents significantly delay the onset of a regular transfusion need in nontransfused patients with lower-risk myelodysplastic syndrome. J Intern Med. 2017 Mar;281(3):284-299. doi: 10.1111/joim.12579. Epub 2016 Dec 7.
Related Links
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European MDS Registry
European MDS network platform
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: 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: 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
Other Identifiers
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883
Identifier Type: -
Identifier Source: org_study_id