Acute Myeloid LeukemiaNCT04460950
Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms
An observational study of Acute Myeloid Leukemia and Familial Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 27 sites in Italy.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Familial Acute Myeloid Leukemia, Myelodysplastic Syndromes
- How many people
- 237 participants
- Where
- 27 sitesItaly
- Study dates
- 16 Dec 2020to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites, 27 recruiting
- Recruiting
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria
Lorella Depaoli, ldepaoli@ospedale.al.it
- Recruiting
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona
Attilio C Olivieri, a.olivieri@univpm.it
- Recruiting
Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto
Avellino
Ilenia Manfra, ilenia.manfra89@gmail.com
- Recruiting
Asl Caserta, Presidio Ospedaliero S.G.Moscati - Aversa - Uo Oncoematologia
Aversa
Clelia Criscuolo, clelia.criscuolo@libero.it
- Recruiting
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna
Stefania Paolini, stefania.paolini@unibo.it
- Recruiting
Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia
Brescia
Domenico Russo
- Recruiting
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia
Alessandria Tucci, alessandra.tucci@asst-spedalicivili.it
- Recruiting
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari
Federica Pilo
- Recruiting
Aou Ospedali Riuniti - Foggia - Uoc Ematologia
Foggia
Celestino Ferradina, ferrandina10@gmail.com
- Recruiting
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
Lecce
Nicola Di Renzo, direnzo.ematolecce@gmail.com
- Recruiting
Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia
Messina
Donato Mannina, donamanni@gmail.com
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan
Rosa Greco, rosa.greco@ospedaleniguarda.it
- Recruiting
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan
Nicola Fracchiolla, ns.fracchiolla@gmail.com
- Recruiting
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano
Daniela E Cilloni, 3332818086, daniela.cilloni@unito.it
- Recruiting
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani
Catello Califano, c.califano@aslsalerno.it
- Recruiting
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo
Maria Enza U Mitra, memitra@yahoo.com
- Recruiting
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma
- Recruiting
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia
Cristina Mecucci, 07557833808, cristina.mecucci@unipg.it
- Recruiting
Aou Pisana - Uo Ematologia Universitaria
Pisa
Sara Galimberti, 050993486, sara.galimberti@med.unipi.it
- Recruiting
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia
Isabella Capodanno, isabella.capodanno@ausl.re.it
- Recruiting
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini
Giulia Tolomelli, giulia.tolomelli@auslromagna.it
- Recruiting
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
Roma
Pasquale Niscola, pniscola@gmail.com
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma
Simona Sica, simona.sica@Unicatt.it
- Recruiting
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo
Nicola Cascavilla, n.cascavilla@operapadrepio.it
- Recruiting
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari
Claudio U Fozza, 3397560639, cfozza@uniss.it
- Recruiting
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino
Luisa Giaccone, luisa.giaccone@unito.it
- Recruiting
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine
Anna C Candoni, candoni.anna@aoud.sanita.fvg.it
About this study
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)
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)
Read the 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.
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year
Secondary outcomes (5)
Hematological characteristics of familial AML/MDSs
Evaluation of hematological characteristics of patients with familial AML/MDS.
Measured: at 1 year
Distribution of familial hematologic neoplasms and/or other cancers
Type and rate of familial hematologic neoplasms and/or other cancers
Measured: at 1 year
Incidence of transplantation
Outcome of transplant in patients with familial AML/MDS
Measured: at 1 year
Survival Distribution
Overall Survival (OS) and Progression Free Survival (PFS)
Measured: at 1 year
Standardized Mortality Ratio (SMR)
SMR to compare the survival risk in patients with familial AML/MDS with the risk in the Italian general population
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start16 Dec 2020
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 237 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460950
- Sponsor's protocol ID
- AML2120
- Status last verified
- Apr 2024
- First submitted
- 25 Jun 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04460950
- Acronym / sponsor ID
- AML2120
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Hematological characteristics of familial AML/MDSs
Time frame: at 1 year
Distribution of familial hematologic neoplasms and/or other cancers
Time frame: at 1 year
Incidence of transplantation
Time frame: at 1 year
Survival Distribution
Time frame: at 1 year
Standardized Mortality Ratio (SMR)
Time frame: at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Familial Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 27 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of familial AML/MDSs (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.