Myelodysplastic Syndromes (MDS)EUMDSNCT00600860
A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
An observational study of Myelodysplastic Syndromes (MDS), run by Radboud University Medical Center at 18 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes (MDS)
- How many people
- 4,000 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Apr 2008to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
Austria1 site, 1 recruiting
- Recruiting
University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology
Innsbruck
Czechia1 site, 1 recruiting
- Recruiting
Institute of Haematology and Blood Transfusion U nemocnice
Prague
France1 site, 1 recruiting
- Recruiting
Hopital Avicenne Universite Paris, Dept of Hematology
Paris
Germany1 site, 1 recruiting
- Recruiting
Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie
Düsseldorf
Greece1 site, 1 recruiting
- Recruiting
University of Patras Medical School, Haematology Division, Dept of Internal Medicine
Pátrai
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center, Dept. of Medicine A
Tel Aviv
Italy1 site, 1 recruiting
- Recruiting
University of Pavia Medical SChool, Dept of Hematology
Pavia
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre, dept of Hematology
Nijmegen
Poland1 site, 1 recruiting
- Recruiting
Medical University, Dept of Hematology, Oncology and Internal Medicine
Warsaw
Portugal1 site, 1 recruiting
- Recruiting
Instituto Português de Oncologia de Lisboa,
Lisbon
Romania1 site, 1 recruiting
- Recruiting
Fundeni CLinical Institute, Clinic of Hematology
Bucharest
Sweden1 site, 1 recruiting
- Recruiting
Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology
Stockholm
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds General Infirmary Dept of Hematology
Leeds
About this study
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 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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes (MDS)
- Being tested
- No interventions
- Keywords
- MDS (all IPSS subtypes), Newly diagnosed
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
Only registration of clinical practice
| Study group | Role | What they receive |
|---|---|---|
| MDS patients | Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
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
Measured: 14.5 years of follow-up (FU)
Secondary outcomes (3)
Correlations
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
Measured: 14.5 years of FU
New prognostic scoring systems
To derive and validate new prognostic scoring systems
Measured: 14.5 years of FU
Scientific research in MDS
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.
Measured: 14.5 years of FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startApr 2008
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic Syndromes (MDS)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bowen, PhD, Study chair, Leeds General InfirmaryTheo de Witte, Prof Dr, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600860
- Sponsor's protocol ID
- 883
- Acronym
- EUMDS
- Status last verified
- Dec 2020
- First submitted
- 14 Jan 2008
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The study results (aggregated data) will be published in an academic journal and presented at scientific meetings. We are working on an update of the website: www.eumds.org. EUMDS related activities and results are also shared via www.mds-europe.eu.
Publications
Culligan D, Taylor A, Smith A, Cargo C, Oster H, Symeonidis A, Stauder R, Langemeijer S, Malcovati L, Fenaux P, Cermak J, Hellstrom-Lindberg E, Mills J, Kotsianidis I, D'Aveni M, van Marrewijk C, Hoeks M, de Witte T, Bowen D, Mittelman M. The Predictive Value of Serum Erythropoietin Levels Measured at Diagnosis in Patients With Myelodysplastic Syndromes. EJHaem. 2026 Jul 29;7(4):e70366. doi: 10.1002/jha2.70366. eCollection 2026 Aug.
PubMed 42529759Zhang Y, Bennett A, Manca A, Mittelman M, Hoeks M, Smith A, Taylor A, Stauder R, de Witte T, Malcovati L, van Marrewijk C, Kreif N. Estimating the Causal Effect of Realistic Treatment Strategies Using Longitudinal Observational Data. Med Decis Making. 2026 Feb;46(2):144-157. doi: 10.1177/0272989X251379819. Epub 2025 Oct 27.
PubMed 41143386Garelius 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.
PubMed 39909656Rombaut 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.
PubMed 39850648Stojkov 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.
PubMed 36607832de 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.
PubMed 31171638Itzykson 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.
PubMed 30126931de 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.
PubMed 29122992Garelius 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.
PubMed 27926979
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00600860
- Acronym / sponsor ID
- EUMDS / 883
- Conditions
- Myelodysplastic Syndromes (MDS)
- Keywords
- MDS (all IPSS subtypes), Newly diagnosed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDS patients | – | Other: No interventionsPatients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic
Key inclusion criteria (11 listed)
- 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
- IPSS and IPSS-R Risk group classification (mandatory)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsOnly registration of clinical practice | Other | MDS patients |
Primary outcome
Demographics
Time frame: 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
3 secondary outcomes
Correlations
Time frame: 14.5 years of FU
New prognostic scoring systems
Time frame: 14.5 years of FU
Scientific research in MDS
Time frame: 14.5 years of FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Derived from this study: PubMed 42529759Culligan D, Taylor A, Smith A, Cargo C, Oster H, Symeonidis A, Stauder R, Langemeijer S, Malcovati L, Fenaux P, Cermak J, Hellstrom-Lindberg E, Mills J, Kotsianidis I, D'Aveni M, van Marrewijk C, Hoeks M, de Witte T, Bowen D, Mittelman M. The Predictive Value of Serum Erythropoietin Levels Measured at Diagnosis in Patients With Myelodysplastic Syndromes. EJHaem. 2026 Jul 29;7(4):e70366. doi: 10.1002/jha2.70366. eCollection 2026 Aug.
- Derived from this study: PubMed 41143386Zhang Y, Bennett A, Manca A, Mittelman M, Hoeks M, Smith A, Taylor A, Stauder R, de Witte T, Malcovati L, van Marrewijk C, Kreif N. Estimating the Causal Effect of Realistic Treatment Strategies Using Longitudinal Observational Data. Med Decis Making. 2026 Feb;46(2):144-157. doi: 10.1177/0272989X251379819. Epub 2025 Oct 27.
- Derived from this study: PubMed 39909656Garelius 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.
- Derived from this study: PubMed 39850648Rombaut 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.
- Derived from this study: PubMed 36607832Stojkov 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.
- Derived from this study: PubMed 31171638de 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.
- Derived from this study: PubMed 30126931Itzykson 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.
- Derived from this study: PubMed 29122992de 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.
- Derived from this study: PubMed 27926979Garelius 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.
- European MDS RegistryLink provided by the sponsor.
- European MDS network platformLink provided by the sponsor.
- 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 concordanceLink provided by the sponsor.
- Publication (PMID: 29122992): Labile plasma iron levels predict survival in patients with lower-risk myelodysplastic syndromesLink provided by the sponsor.
- Publication (PMID: 29407183): Prognostic impact of a suboptimal number of analyzed metaphases in normal karyotype lower-risk MDSLink provided by the sponsor.
- Publication (PMID: 29572506): Health-related quality of life in lower-risk MDS patients compared with age- and sex-matched reference populations: a European LeukemiaNet studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study results (aggregated data) will be published in an academic journal and presented at scientific meetings. We are working on an update of the website: www.eumds.org. EUMDS related activities and results are also shared via www.mds-europe.eu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bowen, PhD study chair
Leeds General Infirmary
Theo de Witte, Prof Dr study director
Radboud University Medical Center
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes (MDS), run by Radboud University Medical Center at 18 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Austria, Croatia, Czechia, Denmark, France and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corine J van Marrewijk, PhD (+31-24-3614794, corine.vanmarrewijk@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: 14.5 years of follow-up (FU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600860, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.