Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT02808858
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2016-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Network MDS Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2032-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of MDS diagnosis', 'timeFrame': '6 years', 'description': 'Number of new cases every 100.000 person/year'}, {'measure': 'Overall Response rate', 'timeFrame': '6 years', 'description': 'Proportion of CR or PR after each line of treatment in term of erythroid, platelet and granulocyte response'}, {'measure': 'Prevalence of MDS', 'timeFrame': '6 years', 'description': 'Number of cases every 100.000 person'}, {'measure': 'Overall survival', 'timeFrame': '6 years', 'description': 'Time between MDS diagnosis and death due to any causes'}, {'measure': 'Progression free survival', 'timeFrame': '6 years', 'description': 'Time between MDS diagnosis and relapse/ progression or death due to any causes'}, {'measure': 'Progression to AML', 'timeFrame': '6 years', 'description': 'Time between MDS diagnosis and Progression to AML or death due to any causes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDS', 'Myelodisplastic Syndrome'], 'conditions': ['Myelodysplastic-Myeloproliferative Diseases']}, 'descriptionModule': {'briefSummary': 'Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS) newly diagnosed.', 'detailedDescription': 'Development of an Italian regional registries MDS network using the same electronic case report form for data storage, with the following broad aims:\n\n* Ability to aggregate and process anonymous epidemiological data collected by individual regional registers;\n* Ability to aggregate the available data with those of other international registries existing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '106 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with new diagnosis of MDS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of MDS\n\nExclusion Criteria:\n\n* Patient who refuse the signature of informed consent'}, 'identificationModule': {'nctId': 'NCT02808858', 'acronym': 'FISM_registry', 'briefTitle': 'Italian Network MDS Registry', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Sindromi Mielodisplastiche-ETS'}, 'officialTitle': 'Rete Italiana Dei Registri Regionali Delle Sindromi Mielodisplastiche (MDS)', 'orgStudyIdInfo': {'id': 'Rete italiana registri MDS'}}, 'contactsLocationsModule': {'locations': [{'zip': '15121', 'city': 'Alessandria', 'state': 'AL', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavia Salvi, MD', 'role': 'CONTACT', 'email': 'fsalvi@ospedale.al.it', 'phone': '+39 0131206066'}, {'name': 'Flavia Salvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ematologia, AO SS. Antonio e Biagio', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '60020', 'city': 'Ancona', 'state': 'AN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Poloni, MD', 'role': 'CONTACT', 'email': 'a.poloni@univpm.it'}, {'name': 'Antonella Poloni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica di Ematologia, AOU Ospedale di Torrette', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '16132', 'city': 'Genova', 'state': 'GE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico Balleari, MD', 'role': 'CONTACT', 'email': 'balleari@unige.it', 'phone': '+39 010 5555784'}, {'name': 'Enrico Balleari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. Clinica Medicina Interna, IRCCS San Martino IST', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '43100', 'city': 'Parma', 'state': 'PR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Crugnola, MD', 'role': 'CONTACT', 'email': 'mo@vodafone.it', 'phone': '+39 0521-702494'}, {'role': 'CONTACT', 'phone': '+39 0521-70'}, {'name': 'Monica Crugnola, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Struttura Cattedra di Ematologia e CTMO, AOU di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '85028', 'city': 'Rionero in Vulture', 'state': 'PZ', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pellegrino Musto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '10060', 'city': 'Candiolo', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elena Crisà , MD', 'role': 'CONTACT', 'email': 'elena.cris@ircc.it', 'phone': '0119933250'}], 'facility': 'FPO - IRCCS di Candiolo', 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'zip': '10128', 'city': 'Torino', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Corrado Tarella, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Asti', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgio Ciravegna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Cardinal Massaia', 'geoPoint': {'lat': 44.90162, 'lon': 8.20751}}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgina Specchia, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ematologia AOU Policlinico di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40100', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Finelli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '09121', 'city': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Angelucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ematologia- Ospedale Businco', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Chieri', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianni Cametti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Maggiore', 'geoPoint': {'lat': 45.01054, 'lon': 7.82133}}, {'zip': '50134', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valeria Santini, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cattedra di Ematologia Policlino Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16132', 'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Riccardo Ghio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dipartimento Emato-Oncologia AOU San Martino Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '10043', 'city': 'Orbassano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Saglio, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giampiero Semenzato, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Maria Liberati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '61122', 'city': 'Pesaro', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Visani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU San Salvatore', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Umberto Vitolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Giovanbni Battista-Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '73039', 'city': 'Tricase', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Pavone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Divisione di Ematologia-Ospedale Cardinale Panico', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}], 'centralContacts': [{'name': 'Valeria Santini, Prof.', 'role': 'CONTACT', 'email': 'segreteriafismonlus@ospedale.al.it', 'phone': '013120', 'phoneExt': '6066'}, {'name': 'Segreteria FISM', 'role': 'CONTACT', 'email': 'segreteriafismonlus@ospedale.al.it', 'phone': '013120', 'phoneExt': '6066'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Sindromi Mielodisplastiche-ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}