Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms
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|ClinicalTrials.gov Identifier: NCT04460950|
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : April 20, 2021
|Condition or disease|
|Acute Myeloid Leukemia Familial Acute Myeloid Leukemia Myelodysplastic Syndromes|
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.
|Study Type :||Observational|
|Estimated Enrollment :||237 participants|
|Official Title:||A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)|
|Actual Study Start Date :||December 16, 2020|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
- Incidence of familial AML/MDSs [ Time Frame: 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.
- Hematological characteristics of familial AML/MDSs [ Time Frame: at 1 year ]Evaluation of hematological characteristics of patients with familial AML/MDS.
- Distribution of familial hematologic neoplasms and/or other cancers [ Time Frame: at 1 year ]Type and rate of familial hematologic neoplasms and/or other cancers
- Incidence of transplantation [ Time Frame: at 1 year ]Outcome of transplant in patients with familial AML/MDS
- Survival Distribution [ Time Frame: at 1 year ]Overall Survival (OS) and Progression Free Survival (PFS)
- Standardized Mortality Ratio (SMR) [ Time Frame: at 1 year ]SMR to compare the survival risk in patients with familial AML/MDS with the risk in the Italian general population
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460950
|Contact: Paola Fazifirstname.lastname@example.org|
|Contact: Enrico Creaemail@example.com|
|Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia||Recruiting|
|Contact: Domenico Russo|