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

December 28, 2020 updated by: Radboud University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria
        • Recruiting
        • University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • Clinical Hospital Merkur
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Institute of Haematology and Blood Transfusion U nemocnice
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
  • France
      • Paris, France
        • Recruiting
        • Hopital Avicenne Universite Paris, Dept of Hematology
  • Germany
      • Dusseldorf, Germany
        • Recruiting
        • Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie
  • Greece
      • Patras, Greece
        • Recruiting
        • University of Patras Medical School, Haematology Division, Dept of Internal Medicine
  • Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Tel-Aviv Sourasky Medical Center, Dept. of Medicine A
  • Italy
      • Pavia, Italy
        • Recruiting
        • University of Pavia Medical SChool, Dept of Hematology
  • Netherlands
      • Nijmegen, Netherlands
        • Recruiting
        • Radboud University Nijmegen Medical Centre, dept of Hematology
  • Poland
      • Warszawa, Poland
        • Recruiting
        • Medical University, Dept of Hematology, Oncology and Internal Medicine
  • Portugal
      • Lisbon, Portugal
        • Recruiting
        • Instituto Português de Oncologia de Lisboa,
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Fundeni CLinical Institute, Clinic of Hematology
  • Serbia
      • Novi Sad, Serbia
        • Recruiting
        • Clinical Center of Vojvodina
  • Spain
      • Valencia, Spain
        • Recruiting
        • Hospital La Fe, Dept of Hematology
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology
  • Switzerland
      • Bern, Switzerland
        • Recruiting
        • Inselspital
  • United Kingdom
      • Leeds, United Kingdom
        • Recruiting
        • Leeds General Infirmary Dept of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14.5 years of follow-up (FU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations
Time Frame: 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
14.5 years of FU
New prognostic scoring systems
Time Frame: 14.5 years of FU
To derive and validate new prognostic scoring systems
14.5 years of FU
Scientific research in MDS
Time Frame: 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.
14.5 years of FU

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dissemination
Time Frame: 14.5 years of FU
To disseminate the results of the studies to all stakeholders involved
14.5 years of FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Study Chair: David Bowen, PhD, Leeds General Infirmary
  • Study Director: Theo de Witte, Prof Dr, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 883

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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