Italian Non-Interventional Study of FLT3 Mutated AML Patients
NCT ID: NCT03547258
Last Updated: 2020-04-21
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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UNKNOWN
800 participants
OBSERVATIONAL
2018-07-18
2021-05-31
Brief Summary
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Detailed Description
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The study will be conducted as follows:
1. Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.
2. Prospective phase: clinical and molecular data of each new FLT3+ AML patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. Every effort will be done to include all consecutive patients, in order to avoid selection bias.
For patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis.
The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected, and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative.
The secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical, molecular and biological information.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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AML patients
Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)
Clinical and Molecular data collection
Clinical and Molecular data collection at diagnosis, during treatment and at each relapse
Interventions
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Clinical and Molecular data collection
Clinical and Molecular data collection at diagnosis, during treatment and at each relapse
Eligibility Criteria
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Inclusion Criteria
2. Male or Female
3. Aged ≥ 18 years
4. FLT3 mutations (ITD or TKD) positive tests performed at diagnosis or at relapse.
5. Participant is willing and able to give informed consent for participation in the study.
18 Years
ALL
No
Sponsors
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER
Responsible Party
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Principal Investigators
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Giovanni Martinelli, MD
Role: STUDY_CHAIR
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Locations
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AOU Ospedali riuniti di Ancona
Ancona, AN, Italy
AOU Policlinico Bari - Ematologia
Bari, BA, Italy
Università di Bologna - DIMES
Bologna, BO, Italy
ASST Spedali di Brescia
Brescia, BS, Italy
Azienda Ospedaliera G. Brotzu
Cagliari, CA, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, Italy
Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
Catanzaro, CZ, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy
AOU Universitaria Arcispedale Sant'Anna
Cona, Ferrara, Italy
IRCCS Casa sollievo della sofferenza
San Giovanni Rotondo, FG, Italy
AOU Careggi
Florence, FI, Italy
Ospedale Vito Fazzi di Lecce
Lecce, LE, Italy
AOU Policlinico Gaetano Martino
Messina, ME, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, Italy
Ospedale San Raffaele
Milan, MI, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
Ospedali Riuniti Villa Sofia-Cervello
Palermo, PA, Italy
Ospedale "Guglielmo da Saliceto"
Piacenza, PC, Italy
Irccs Crob
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO
Parma, PR, Italy
UO Ematologia, Ospedale S.Maria delle Croci
Ravenna, RA, Italy
Grande Ospedale Metropolitano
Reggio Calabria, RC, Italy
Ospedale infermi di Rimini
Rimini, RN, Italy
AOU San Giovannidi Dio e Ruggi - ematologia
Salerno, SA, Italy
AOC di Ematologia - AOU Senese
Siena, SI, Italy
Università di Torino - Ospedale San Luigi Gonzaga
Orbassano, TO, Italy
AOU Città della Salute e della Scienza di Torino
Torino, TO, Italy
A.O. Ordine Mauriziano Torino
Torino, TO, Italy
Divisione di Ematologia - Università di Udine
Udine, UD, Italy
AO Universitaria Federico II
Napoli, , Italy
AOU Maggiore della carità
Novara, , Italy
AOU Santa Maria della Misericordia - Ematologia
Perugia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Attilio Olivieri
Role: primary
Francesco Albano
Role: primary
Cristina Papayannidis
Role: primary
Chiara Cattaneo
Role: primary
Claudio Romani
Role: primary
Daniele Mattei
Role: primary
Stefano Molica
Role: primary
Gian Matteo Rigolin, Prof
Role: primary
Nicola Cascavilla, DR
Role: primary
Alberto Bosi
Role: primary
Nicola Di Renzo, DR
Role: primary
Caterina Musolino
Role: primary
Nicola Stefano Fracchiolla, MD
Role: primary
Fabio Ciceri
Role: primary
Elisabetta Todisco
Role: primary
Francesco Fabbiano
Role: primary
Daniele Vallisa
Role: primary
Pellegrino Mustu
Role: primary
Giovanni Roti
Role: primary
Francesco Lanza, MD
Role: primary
Esther Oliva
Role: primary
Anna Maria Mianulli, MD
Role: primary
Carmine Selleri
Role: primary
Monica Bocchia
Role: primary
Daniela Cilloni
Role: primary
Ernesta Audisio
Role: primary
Alessandro Cignetti
Role: primary
Anna Candoni
Role: primary
Fabrizio Pane
Role: primary
Monia Lunghi, MD, PhD
Role: primary
Maria Paola Martelli, Prof.ssa
Role: primary
Simona Sica, Prof
Role: primary
Other Identifiers
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IRST204.01
Identifier Type: -
Identifier Source: org_study_id
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