Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
1 other identifier
observational
388
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Start
First participant enrolled
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2021
CompletedJanuary 4, 2022
September 1, 2021
3.4 years
December 6, 2016
December 31, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (1)
AML patients
Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Interventions
Observation of the test result.
Eligibility Criteria
Adult AML patients
You may qualify if:
- 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.
You may not qualify if:
- AML M3 subtype according to the FAB classification;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Martinelli
Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
- STUDY DIRECTOR
Maria Teresa Voso
U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 8, 2016
Study Start
October 31, 2017
Primary Completion
March 22, 2021
Study Completion
March 22, 2021
Last Updated
January 4, 2022
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share