Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms
A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)
1 other identifier
observational
237
1 country
27
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
July 8, 2020
CompletedStudy Start
First participant enrolled
December 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedApril 10, 2024
April 1, 2024
4.2 years
June 25, 2020
April 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of familial AML/MDSs
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.
at 1 year
Secondary Outcomes (5)
Hematological characteristics of familial AML/MDSs
at 1 year
Distribution of familial hematologic neoplasms and/or other cancers
at 1 year
Incidence of transplantation
at 1 year
Survival Distribution
at 1 year
Standardized Mortality Ratio (SMR)
at 1 year
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, Italy
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
Avellino, Italy
Asl Caserta, Presidio Ospedaliero S.G.Moscati - Aversa - Uo Oncoematologia
Aversa, Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, Italy
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
Brescia, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia, Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, Italy
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
Foggia, Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce, Italy
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, 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
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
Aou Pisana - Uo Ematologia Universitaria
Pisa, Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini, Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
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
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2020
First Posted
July 8, 2020
Study Start
December 16, 2020
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
April 10, 2024
Record last verified: 2024-04