A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
- Conditions
- Myelodysplastic Syndromes (MDS)
- Interventions
- Other: No interventions
- Registration Number
- NCT00600860
- Lead Sponsor
- Radboud University Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4000
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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MDS patients No interventions Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification
- Primary Outcome Measures
Name Time Method Demographics 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
- Secondary Outcome Measures
Name Time Method Correlations 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 EconomicsNew prognostic scoring systems 14.5 years of FU To derive and validate new prognostic scoring systems
Scientific research in MDS 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.
Trial Locations
- Locations (18)
University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology
🇦🇹Innsbruck, Austria
Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie
🇩🇪Dusseldorf, Germany
Institute of Haematology and Blood Transfusion U nemocnice
🇨🇿Prague, Czechia
University of Patras Medical School, Haematology Division, Dept of Internal Medicine
🇬🇷Patras, Greece
Tel-Aviv Sourasky Medical Center, Dept. of Medicine A
🇮🇱Tel-Aviv, Israel
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Clinical Hospital Merkur
🇭🇷Zagreb, Croatia
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Medical University, Dept of Hematology, Oncology and Internal Medicine
🇵🇱Warszawa, Poland
Instituto Português de Oncologia de Lisboa,
🇵🇹Lisbon, Portugal
Inselspital
🇨🇭Bern, Switzerland
University of Pavia Medical SChool, Dept of Hematology
🇮🇹Pavia, Italy
Hopital Avicenne Universite Paris, Dept of Hematology
🇫🇷Paris, France
Radboud University Nijmegen Medical Centre, dept of Hematology
🇳🇱Nijmegen, Netherlands
Fundeni CLinical Institute, Clinic of Hematology
🇷🇴Bucharest, Romania
Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology
🇸🇪Stockholm, Sweden
Hospital La Fe, Dept of Hematology
🇪🇸Valencia, Spain
Leeds General Infirmary Dept of Hematology
🇬🇧Leeds, United Kingdom