Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT04460950
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2020-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 237}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of familial AML/MDSs', 'timeFrame': 'at 1 year', 'description': 'Evaluation of incidence of familial AML/MDSs in patients with de novo MDSs or AML with almost one relative affected by hematologic neoplasms and/or other cancers at young age (\\< 40 years). The incidence of familial AML/MDSs will be evaluated by means of number of diagnosis of familial AML/MDSs on the number of all diagnosis of AML/MDS between January 2014 and December 2022.'}], 'secondaryOutcomes': [{'measure': 'Hematological characteristics of familial AML/MDSs', 'timeFrame': 'at 1 year', 'description': 'Evaluation of hematological characteristics of patients with familial AML/MDS.'}, {'measure': 'Distribution of familial hematologic neoplasms and/or other cancers', 'timeFrame': 'at 1 year', 'description': 'Type and rate of familial hematologic neoplasms and/or other cancers'}, {'measure': 'Incidence of transplantation', 'timeFrame': 'at 1 year', 'description': 'Outcome of transplant in patients with familial AML/MDS'}, {'measure': 'Survival Distribution', 'timeFrame': 'at 1 year', 'description': 'Overall Survival (OS) and Progression Free Survival (PFS)'}, {'measure': 'Standardized Mortality Ratio (SMR)', 'timeFrame': 'at 1 year', 'description': 'SMR to compare the survival risk in patients with familial AML/MDS with the risk in the Italian general population'}]}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Familial Acute Myeloid Leukemia', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'Observational study aimed at evaluating the incidence of familial AML/MDSs in patients with de novo MDSs or AML with almost one relative affected by hematologic neoplasms and/or other cancers at young age (\\< 40 years)', 'detailedDescription': 'This is a multicenter, retrospective and prospective, observational study aims to collect clinical information on patients with familial AML/MDSs from January 2014 to December 2022. No intervention is expected.\n\nThe purpose of this study is to identify and characterize the patients with familial MDSs or AML (i.e. with relatives affected by hematologic neoplasms and/or other cancers at young age (\\< 40 years)) or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs.\n\nIn order to estimate the incidence of familial AML/MDSs, a survey will be sent every year to all participating sites to collect only the number of the all diagnosis of AML/MDS. All patients will be followed until December 2023 in order to have at least 1 year of observation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnoses with AML and MDSs from January 2014 to December 2022 will be registered. Study population will include patients with MDSs or AML with at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age \\< 40 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age \\> 18 years old\n* Diagnosis of AML or MDSs from January 2014 to December 2022\n* Suspected familiarity for myeloid neoplasm: at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age \\< 40 years or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs\n* Signed written informed consent according to ICH/EU/GCP and national local laws.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04460950', 'briefTitle': 'Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)', 'orgStudyIdInfo': {'id': 'AML2120'}}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorella Depaoli', 'role': 'CONTACT', 'email': 'ldepaoli@ospedale.al.it'}], 'facility': 'Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Attilio C Olivieri', 'role': 'CONTACT', 'email': 'a.olivieri@univpm.it'}], 'facility': 'Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ilenia Manfra', 'role': 'CONTACT', 'email': 'ilenia.manfra89@gmail.com'}], 'facility': 'Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Aversa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clelia Criscuolo', 'role': 'CONTACT', 'email': 'clelia.criscuolo@libero.it'}], 'facility': 'Asl Caserta, Presidio Ospedaliero S.G.Moscati - Aversa - Uo Oncoematologia', 'geoPoint': {'lat': 40.97259, 'lon': 14.20745}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefania Paolini', 'role': 'CONTACT', 'email': 'stefania.paolini@unibo.it'}], 'facility': 'Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Russo', 'role': 'CONTACT'}], 'facility': 'Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandria Tucci', 'role': 'CONTACT', 'email': 'alessandra.tucci@asst-spedalicivili.it'}], 'facility': 'Asst Degli Spedali Civili Di Brescia - Uo Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Pilo', 'role': 'CONTACT'}], 'facility': 'Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Foggia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Celestino Ferradina', 'role': 'CONTACT', 'email': 'ferrandina10@gmail.com'}], 'facility': 'Aou Ospedali Riuniti - Foggia - Uoc Ematologia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Lecce', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Di Renzo', 'role': 'CONTACT', 'email': 'direnzo.ematolecce@gmail.com'}], 'facility': "Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia", 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Donato Mannina', 'role': 'CONTACT', 'email': 'donamanni@gmail.com'}], 'facility': 'Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rosa Greco', 'role': 'CONTACT', 'email': 'rosa.greco@ospedaleniguarda.it'}], 'facility': 'Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Fracchiolla', 'role': 'CONTACT', 'email': 'ns.fracchiolla@gmail.com'}], 'facility': "Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Orbassano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela E Cilloni', 'role': 'CONTACT', 'email': 'daniela.cilloni@unito.it', 'phone': '3332818086'}], 'facility': 'Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Pagani', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Catello Califano', 'role': 'CONTACT', 'email': 'c.califano@aslsalerno.it'}], 'facility': 'Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia', 'geoPoint': {'lat': 40.74199, 'lon': 14.61448}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Enza U Mitra', 'role': 'CONTACT', 'email': 'memitra@yahoo.com'}], 'facility': 'Aou Policlinico P. Giaccone - Palermo - Uo Ematologia', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Mecucci', 'role': 'CONTACT', 'email': 'cristina.mecucci@unipg.it', 'phone': '07557833808'}], 'facility': 'Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Galimberti', 'role': 'CONTACT', 'email': 'sara.galimberti@med.unipi.it', 'phone': '050993486'}], 'facility': 'Aou Pisana - Uo Ematologia Universitaria', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Isabella Capodanno', 'role': 'CONTACT', 'email': 'isabella.capodanno@ausl.re.it'}], 'facility': 'Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulia Tolomelli', 'role': 'CONTACT', 'email': 'giulia.tolomelli@auslromagna.it'}], 'facility': 'Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pasquale Niscola', 'role': 'CONTACT', 'email': 'pniscola@gmail.com'}], 'facility': 'Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Sica', 'role': 'CONTACT', 'email': 'simona.sica@Unicatt.it'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Cascavilla', 'role': 'CONTACT', 'email': 'n.cascavilla@operapadrepio.it'}], 'facility': 'Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Sassari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio U Fozza', 'role': 'CONTACT', 'email': 'cfozza@uniss.it', 'phone': '3397560639'}], 'facility': 'Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luisa Giaccone', 'role': 'CONTACT', 'email': 'luisa.giaccone@unito.it'}], 'facility': 'Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna C Candoni', 'role': 'CONTACT', 'email': 'candoni.anna@aoud.sanita.fvg.it'}], 'facility': 'Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}