Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms

NCT ID: NCT04460950

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

237 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-16

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Acute Myeloid Leukemia Familial Acute Myeloid Leukemia Myelodysplastic Syndromes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

Alessandria, , Italy

Site Status RECRUITING

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica

Ancona, , Italy

Site Status RECRUITING

Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto

Avellino, , Italy

Site Status RECRUITING

Asl Caserta, Presidio Ospedaliero S.G.Moscati - Aversa - Uo Oncoematologia

Aversa, , Italy

Site Status RECRUITING

Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

Bologna, , Italy

Site Status RECRUITING

Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia

Brescia, , Italy

Site Status RECRUITING

Asst Degli Spedali Civili Di Brescia - Uo Ematologia

Brescia, , Italy

Site Status RECRUITING

Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

Cagliari, , Italy

Site Status RECRUITING

Aou Ospedali Riuniti - Foggia - Uoc Ematologia

Foggia, , Italy

Site Status RECRUITING

Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia

Lecce, , Italy

Site Status RECRUITING

Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia

Messina, , Italy

Site Status RECRUITING

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

Milan, , Italy

Site Status RECRUITING

Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora

Milan, , Italy

Site Status RECRUITING

Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia

Orbassano, , Italy

Site Status RECRUITING

Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia

Pagani, , Italy

Site Status RECRUITING

Aou Policlinico P. Giaccone - Palermo - Uo Ematologia

Palermo, , Italy

Site Status RECRUITING

Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo

Parma, , Italy

Site Status RECRUITING

Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo

Perugia, , Italy

Site Status RECRUITING

Aou Pisana - Uo Ematologia Universitaria

Pisa, , Italy

Site Status RECRUITING

Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

Reggio Emilia, , Italy

Site Status RECRUITING

Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia

Rimini, , Italy

Site Status RECRUITING

Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia

Roma, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, , Italy

Site Status RECRUITING

Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

San Giovanni Rotondo, , Italy

Site Status RECRUITING

Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia

Sassari, , Italy

Site Status RECRUITING

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

Torino, , Italy

Site Status RECRUITING

Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica

Udine, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Fazi

Role: CONTACT

0670390528

Enrico Crea

Role: CONTACT

0670390514

Facility Contacts

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Lorella Depaoli

Role: primary

Attilio C Olivieri

Role: primary

Ilenia Manfra

Role: primary

Clelia Criscuolo

Role: primary

Stefania Paolini

Role: primary

Domenico Russo

Role: primary

Alessandria Tucci

Role: primary

Federica Pilo

Role: primary

Celestino Ferradina

Role: primary

Nicola Di Renzo

Role: primary

Donato Mannina

Role: primary

Rosa Greco

Role: primary

Nicola Fracchiolla

Role: primary

Daniela E Cilloni

Role: primary

3332818086

Catello Califano

Role: primary

Maria Enza U Mitra

Role: primary

Cristina Mecucci

Role: primary

07557833808

Sara Galimberti

Role: primary

050993486

Isabella Capodanno

Role: primary

Giulia Tolomelli

Role: primary

Pasquale Niscola

Role: primary

Simona Sica

Role: primary

Nicola Cascavilla

Role: primary

Claudio U Fozza

Role: primary

3397560639

Luisa Giaccone

Role: primary

Anna C Candoni

Role: primary

Other Identifiers

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AML2120

Identifier Type: -

Identifier Source: org_study_id

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