Clinical trial · Observational
A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
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)
NCT00600860CI-TRIAL-00049195EUMDSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndromes (MDS) | Myelodysplastic Syndrome | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No interventions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MDS patients
- description
- Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification
- interventionNames
- Other: No interventions
Primary outcomes (1)
- measure
- Demographics
- timeFrame
- 14.5 years of follow-up (FU)
- description
- 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 outcomes (3)
- measure
- Correlations
- timeFrame
- 14.5 years of FU
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) * 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
References
Publications (9)
- DERIVEDCulligan 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. PMID 42529759
- DERIVEDZhang 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. PMID 41143386
- DERIVEDGarelius 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. PMID 39909656
- DERIVEDRombaut 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. PMID 39850648
- DERIVEDStojkov 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.