Spots Global Cancer Trial Database for A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
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Trial Identification
Brief Title: A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
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 ID: NCT00600860
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology, Innsbruck, , Austria
Clinical Hospital Merkur, Zagreb, , Croatia
Institute of Haematology and Blood Transfusion U nemocnice, Prague, , Czechia
Aarhus University Hospital, Aarhus, , Denmark
Hopital Avicenne Universite Paris, Dept of Hematology, Paris, , France
Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie, Dusseldorf, , Germany
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
University of Pavia Medical SChool, Dept of Hematology, Pavia, , Italy
Radboud University Nijmegen Medical Centre, dept of Hematology, Nijmegen, , Netherlands
Medical University, Dept of Hematology, Oncology and Internal Medicine, Warszawa, , Poland
Instituto Português de Oncologia de Lisboa,, Lisbon, , Portugal
Fundeni CLinical Institute, Clinic of Hematology, Bucharest, , Romania
Clinical Center of Vojvodina, Novi Sad, , Serbia
Hospital La Fe, Dept of Hematology, Valencia, , Spain
Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology, Stockholm, , Sweden
Inselspital, Bern, , Switzerland
Leeds General Infirmary Dept of Hematology, Leeds, , United Kingdom
Contact Details
Name: David Bowen, PhD
Affiliation: Leeds General Infirmary
Role: STUDY_CHAIR
Name: Theo de Witte, Prof Dr
Affiliation: Radboud University Medical Center
Role: STUDY_DIRECTOR
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