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Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Completed
Conditions
AML, Adult
Interventions
Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Registration Number
NCT02986620
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
388
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
AML patientsIDH mutation test performed at diagnosis or relapse until January 31st, 2019.Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Primary Outcome Measures
NameTimeMethod
Number of patients with the IDH mutations in AML at initial diagnosis.At two years from study entry.
Number of patients with the IDH mutations in AML at relapse.At three years from study entry.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (24)

AOU Policlinico G. Martino

🇮🇹

Messina, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

🇮🇹

Milano, Italy

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

🇮🇹

Padova, 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

I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica

🇮🇹

Meldola, Italy

AU Policlinico "Paiolo Giaccone"

🇮🇹

Palermo, Italy

Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia

🇮🇹

Perugia, Italy

Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia

🇮🇹

Brindisi, Italy

IFO Istituto Nazionale Tumori Regina Elena

🇮🇹

Roma, Italy

UO Ematologia _AOU Policlinico di Modena

🇮🇹

Modena, Italy

Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo

🇮🇹

Palermo, Italy

Università Cattolica del Sacro Cuore - Policlinico A.Gemelli

🇮🇹

Roma, Italy

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

🇮🇹

Alessandria, Italy

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

🇮🇹

Bari, Italy

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

🇮🇹

Milano, Italy

Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia

🇮🇹

Milano, Italy

Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo

🇮🇹

Parma, Italy

Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

🇮🇹

Piacenza, Italy

Università degli Studi - Policlinico di Tor Vergata

🇮🇹

Roma, Italy

Università degli Studi - Policlinico Tor Vergata

🇮🇹

Rome, Italy

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

🇮🇹

Bologna, Italy

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

🇮🇹

Bologna, Italy

Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

🇮🇹

Milano, Italy

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