Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-04-10 @ 10:20 PM
Study NCT ID:
NCT00600860
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2008-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and Bone marrow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2008-01-14', 'studyFirstSubmitQcDate': '2008-01-24', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dissemination', 'timeFrame': '14.5 years of FU', 'description': 'To disseminate the results of the studies to all stakeholders involved'}], 'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Correlations', 'timeFrame': '14.5 years of FU', 'description': 'To investigate the relationship between:\n\n* Clinical characteristics at inclusion and during follow-up\n* Treatments received, including transfusions, and\n* Responses to treatment\n* Overall survival\n* Disease progression\n* General and disease specific HRQoL, and Karnofsky Performance Status\n* Health Economics'}, {'measure': 'New prognostic scoring systems', 'timeFrame': '14.5 years of FU', 'description': 'To derive and validate new prognostic scoring systems'}, {'measure': 'Scientific research in MDS', 'timeFrame': '14.5 years of FU', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDS (all IPSS subtypes)', 'Newly diagnosed'], 'conditions': ['Myelodysplastic Syndromes (MDS)']}, 'referencesModule': {'references': [{'pmid': '39909656', 'type': 'DERIVED', 'citation': "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': '39850648', 'type': 'DERIVED', 'citation': "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': '36607832', 'type': 'DERIVED', 'citation': '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': '31171638', 'type': 'DERIVED', 'citation': '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': '30126931', 'type': 'DERIVED', 'citation': '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': '29122992', 'type': 'DERIVED', 'citation': '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': '27926979', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.eumds.org', 'label': 'European MDS Registry'}, {'url': 'https://mds-europe.eu/', 'label': 'European MDS network platform'}, {'url': 'https://link.springer.com/article/10.1007%2Fs00277-017-3009-7', 'label': 'Publication (PMID: 28526957): Cytomorphology review of 100 newly diagnosed lower-risk MDS patients in the European LeukemiaNet MDS (EUMDS) registry reveals a high inter-observer concordance'}, {'url': 'http://www.haematologica.org/content/103/1/69.long', 'label': 'Publication (PMID: 29122992): Labile plasma iron levels predict survival in patients with lower-risk myelodysplastic syndromes'}, {'url': 'https://www.nature.com/articles/s41375-018-0089-x', 'label': 'Publication (PMID: 29572506): Health-related quality of life in lower-risk MDS patients compared with age- and sex-matched reference populations: a European LeukemiaNet study'}, {'url': 'http://www.haematologica.org/content/early/2019/06/05/haematol.2018.212217.long', 'label': 'Publication (PMID: 31171638): Impact of red blood cell transfusion dose density on progression-free survival in lower-risk myelodysplastic syndromes patients'}, {'url': 'http://www.haematologica.org/content/early/2019/07/05/haematol.2018.212332.long', 'label': 'Publication (PMID: 31278207): Impact of treatment with iron chelation therapy in patients with lower-risk myelodysplastic syndromes participating in the European MDS registry'}]}, 'descriptionModule': {'briefSummary': 'Study Objectives:\n\nTo 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.\n\nTo 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.\n\nTo disseminate results of the studies to all stakeholders involved.', 'detailedDescription': 'Methodology:\n\nData 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.\n\nNumber 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.\n\nPopulation:\n\nThe 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.\n\nStudy Duration:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet all of the following criteria\n\n* Age \\> 18 years\n* Newly diagnosed patient (within 100 days from the date of the diagnostic bone marrow (BM) aspirate)\n* MDS classified according to current WHO criteria\n\n * All sub groups of MDS\n * Therapy-related MDS\n * MDS with Fibrosis (MDS-F)\n * AML with 20-\\<30 percent marrow blasts (former RAEB-t)\n * CMML and other forms of mixed MDS/MPD\n* IPSS and IPSS-R Risk group classification (mandatory)\n* Able and willing to provide the written informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Patient unwilling or unable to give consent\n* AML with ≥30 percent marrow blasts according to WHO\n* Patients with inv(16), t(5;17) and t(8;21) are considered AML and therefore not eligible\n* 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'}, 'identificationModule': {'nctId': 'NCT00600860', 'acronym': 'EUMDS', 'briefTitle': 'A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '883'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDS patients', 'description': 'Patients with MDS according to current WHO criteria and International Prognostic Scoring System (IPSS) classification', 'interventionNames': ['Other: No interventions']}], 'interventions': [{'name': 'No interventions', 'type': 'OTHER', 'description': 'Only registration of clinical practice', 'armGroupLabels': ['MDS patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'University of Innsbruck Fachartz fur Innere Medizin, Dept of Hematology', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'facility': 'Clinical Hospital Merkur', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'facility': 'Institute of Haematology and Blood Transfusion U nemocnice', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Avicenne Universite Paris, Dept of Hematology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Medizinische Klinik und Poliklinik fur Haematologie, Onkologie und Klinische Immunologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Pátrai', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'University of Patras Medical School, Haematology Division, Dept of Internal Medicine', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center, Dept. of Medicine A', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'University of Pavia Medical SChool, Dept of Hematology', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Centre, dept of Hematology', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Medical University, Dept of Hematology, Oncology and Internal Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Instituto Português de Oncologia de Lisboa,', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'facility': 'Fundeni CLinical Institute, Clinic of Hematology', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Novi Sad', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Clinical Center of Vojvodina', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital La Fe, Dept of Hematology', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Karolinsky Institute Huddinge University Hospital, Dept of Medicine Division HAematology', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Leeds', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary Dept of Hematology', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Corine J van Marrewijk, PhD', 'role': 'CONTACT', 'email': 'corine.vanmarrewijk@radboudumc.nl', 'phone': '+31-24-3614794'}, {'name': 'Rosalie Lubbers, MSc', 'role': 'CONTACT', 'email': 'rosalie.lubbers@radboudumc.nl', 'phone': '+31-24-3614794'}], 'overallOfficials': [{'name': 'David Bowen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leeds General Infirmary'}, {'name': 'Theo de Witte, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}