Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms
- Conditions
- Acute Myeloid LeukemiaFamilial Acute Myeloid LeukemiaMyelodysplastic Syndromes
- Registration Number
- NCT04460950
- Brief Summary
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)
- Detailed Description
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.
The 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.
In 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 237
- Patient age > 18 years old
- Diagnosis of AML or MDSs from January 2014 to December 2022
- 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
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of familial AML/MDSs at 1 year 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.
- Secondary Outcome Measures
Name Time Method Hematological characteristics of familial AML/MDSs at 1 year Evaluation of hematological characteristics of patients with familial AML/MDS.
Standardized Mortality Ratio (SMR) at 1 year SMR to compare the survival risk in patients with familial AML/MDS with the risk in the Italian general population
Distribution of familial hematologic neoplasms and/or other cancers at 1 year Type and rate of familial hematologic neoplasms and/or other cancers
Incidence of transplantation at 1 year Outcome of transplant in patients with familial AML/MDS
Survival Distribution at 1 year Overall Survival (OS) and Progression Free Survival (PFS)
Trial Locations
- Locations (27)
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
🇮🇹Roma, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
🇮🇹Milano, Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
🇮🇹Bologna, Italy
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
🇮🇹Foggia, Italy
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
🇮🇹Avellino, Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
🇮🇹Cagliari, Italy
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
🇮🇹Messina, Italy
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
🇮🇹Alessandria, Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
🇮🇹Lecce, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
🇮🇹Torino, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
🇮🇹Perugia, Italy
Aou Pisana - Uo Ematologia Universitaria
🇮🇹Pisa, Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
🇮🇹Parma, Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
🇮🇹Rimini, Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
🇮🇹Udine, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
🇮🇹Ancona, Italy
Asl Caserta, Presidio Ospedaliero S.G.Moscati - Aversa - Uo Oncoematologia
🇮🇹Aversa, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
🇮🇹Brescia, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
🇮🇹Milano, Italy
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
🇮🇹Brescia, Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
🇮🇹Orbassano, Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
🇮🇹Pagani, Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
🇮🇹Palermo, Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
🇮🇹Reggio Emilia, Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
🇮🇹Roma, Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
🇮🇹San Giovanni Rotondo, Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
🇮🇹Sassari, Italy