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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

4,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach

17 countries

17 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.3 years study duration

First Submitted

Initial submission to the registry

January 14, 2008

Completed

11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed

2 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed

14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed

Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

14.8 years

First QC Date

January 14, 2008

Last Update Submit

December 28, 2020

Conditions

Myelodysplastic Syndromes (MDS)

Keywords

MDS (all IPSS subtypes)Newly diagnosed

Outcome Measures

Primary Outcomes (1)

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
14.5 years of follow-up (FU)

Secondary Outcomes (3)

Correlations
14.5 years of FU
New prognostic scoring systems
14.5 years of FU
Scientific research in MDS
14.5 years of FU

Other Outcomes (1)

Dissemination
14.5 years of FU

Study Arms (1)

MDS patients

Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification

Other: No interventions

Interventions

No interventionsOTHER

Only registration of clinical practice

MDS patients

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Radboud University Medical Centerlead

Study Sites (18)

University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology

Innsbruck, Austria

RECRUITING

Clinical Hospital Merkur

Zagreb, Croatia

RECRUITING

Institute of Haematology and Blood Transfusion U nemocnice

Prague, Czechia

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Hopital Avicenne Universite Paris, Dept of Hematology

Paris, France

RECRUITING

Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie

Düsseldorf, Germany

RECRUITING

University of Patras Medical School, Haematology Division, Dept of Internal Medicine

Pátrai, Greece

RECRUITING

Tel-Aviv Sourasky Medical Center, Dept. of Medicine A

Tel Aviv, Israel

RECRUITING

University of Pavia Medical SChool, Dept of Hematology

Pavia, Italy

RECRUITING

Radboud University Nijmegen Medical Centre, dept of Hematology

Nijmegen, Netherlands

RECRUITING

Medical University, Dept of Hematology, Oncology and Internal Medicine

Warsaw, Poland

RECRUITING

Instituto Português de Oncologia de Lisboa,

Lisbon, Portugal

RECRUITING

Fundeni CLinical Institute, Clinic of Hematology

Bucharest, Romania

RECRUITING

Clinical Center of Vojvodina

Novi Sad, Serbia

RECRUITING

Hospital La Fe, Dept of Hematology

Valencia, Spain

RECRUITING

Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology

Stockholm, Sweden

RECRUITING

Inselspital

Bern, Switzerland

RECRUITING

Leeds General Infirmary Dept of Hematology

Leeds, United Kingdom

RECRUITING

Related Publications (7)

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.
PMID: 39909656DERIVED
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.
PMID: 39850648DERIVED
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.
PMID: 36607832DERIVED
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.
PMID: 31171638DERIVED
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.
PMID: 30126931DERIVED
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.
PMID: 29122992DERIVED
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.
PMID: 27926979DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Bone marrow

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

David Bowen, PhD
Leeds General Infirmary
STUDY CHAIR
Theo de Witte, Prof Dr
Radboud University Medical Center
STUDY DIRECTOR

Central Study Contacts

Corine J van Marrewijk, PhD

CONTACT

+31-24-3614794 corine.vanmarrewijk@radboudumc.nl

Rosalie Lubbers, MSc

CONTACT

+31-24-3614794 rosalie.lubbers@radboudumc.nl

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

April 1, 2008

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

December 30, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing: Will not share

Locations

PL(1)DE(1)ES(1)PT(1)CR(1)CZ(1)AU(1)SE(1)DK(1)IT(1)IL(1)NL(1)RO(1)GB(1)CH(1)FR(1)GR(1)

A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (1)

MDS patients

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (7)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (1)

MDS patients

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (7)

Related Links

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations