Clinical trial NCT02986620: Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
Official title: Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AML, Adult
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult AML patients

Brief summary: This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.

This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Detailed description: The study will be conducted as follows:

1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).
2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Eligibility criteria: Inclusion criteria:

* Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);
* AML patients;
* Age ≥18;
* IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Exclusion criteria:

* AML M3 subtype according to the FAB classification;

Primary outcomes:
measure: Number of patients with the IDH mutations in AML at initial diagnosis.
timeFrame: At two years from study entry.
measure: Number of patients with the IDH mutations in AML at relapse.
timeFrame: At three years from study entry.
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
city: Bari
country: Italy
facility: Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
city: Bologna
country: Italy
facility: Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
city: Bologna
country: Italy
facility: Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
city: Brindisi
country: Italy
facility: Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
city: Meldola
country: Italy
facility: I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
city: Messina
country: Italy
facility: AOU Policlinico G. Martino
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
city: Milano
country: Italy
facility: Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
city: Modena
country: Italy
facility: UO Ematologia _AOU Policlinico di Modena
city: Padova
country: Italy
facility: Università degli Studi di Padova - Ematologia ed Immunologia Clinica
city: Palermo
country: Italy
facility: Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
city: Palermo
country: Italy
facility: AU Policlinico "Paiolo Giaccone"
city: Parma
country: Italy
facility: Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
city: Perugia
country: Italy
facility: Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia
city: Piacenza
country: Italy
facility: Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
city: Roma
country: Italy
facility: IFO Istituto Nazionale Tumori Regina Elena
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
city: Roma
country: Italy
facility: Università degli Studi - Policlinico di Tor Vergata
city: Rome
country: Italy
facility: Università degli Studi - Policlinico Tor Vergata
city: San Giovanni Rotondo
country: Italy
facility: Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
city: Udine
country: Italy
facility: Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Study officials:
affiliation: Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
name: Giovanni Martinelli
role: STUDY_CHAIR
affiliation: U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome
name: Maria Teresa Voso
role: STUDY_DIRECTOR
References: