Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
NCT ID: NCT02986620
Last Updated: 2022-01-04
Study Results
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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COMPLETED
388 participants
OBSERVATIONAL
2017-10-31
2021-03-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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AML patients
Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Observation of the test result.
Interventions
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IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Observation of the test result.
Eligibility Criteria
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Inclusion Criteria
* AML patients;
* Age ≥18;
* IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Giovanni Martinelli
Role: STUDY_CHAIR
Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
Maria Teresa Voso
Role: STUDY_DIRECTOR
U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome
Locations
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Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, , Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, , Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, , Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, , Italy
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
Brindisi, , Italy
I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
Meldola, , Italy
AOU Policlinico G. Martino
Messina, , Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan, , Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan, , Italy
Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
Milan, , Italy
UO Ematologia _AOU Policlinico di Modena
Modena, , Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padua, , Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, , Italy
AU Policlinico "Paiolo Giaccone"
Palermo, , Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, , Italy
Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia
Perugia, , Italy
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, , Italy
IFO Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
Roma, , Italy
Università degli Studi - Policlinico di Tor Vergata
Roma, , Italy
Università degli Studi - Policlinico Tor Vergata
Rome, , Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, , Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, , Italy
Countries
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Other Identifiers
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AML1516
Identifier Type: -
Identifier Source: org_study_id
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