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

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ClinicalTrials.gov Identifier: NCT02986620
Recruitment Status : Unknown
Verified May 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Recruiting
First Posted : December 8, 2016
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
AML, Adult Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 232 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020


Group/Cohort Intervention/treatment
AML patients
Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Observation of the test result.




Primary Outcome Measures :
  1. Number of patients with the IDH mutations in AML at initial diagnosis. [ Time Frame: At two years from study entry. ]
  2. Number of patients with the IDH mutations in AML at relapse. [ Time Frame: At three years from study entry. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult AML patients
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986620


Contacts
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Contact: Paola Fazi +39 06.70390521 p.fazi@gimema.it
Contact: Enrico Crea e.crea@gimema.it

Locations
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Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Not yet recruiting
Bologna, Italy
Contact: Giovanni Martinelli         
Principal Investigator: Giovanni Martinelli         
Sub-Investigator: Emanuela Ottaviani         
AOU Policlinico G. Martino Not yet recruiting
Messina, Italy
Contact: Caterina Musolino         
Principal Investigator: Caterina Musolino         
Sub-Investigator: Demetrio Gerace         
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano Recruiting
Milano, Italy
Contact: Nicola Fracchiolla         
Principal Investigator: Nicola Fracchiolla         
UO Ematologia _AOU Policlinico di Modena Recruiting
Modena, Italy
Contact: Fabio Forghieri         
Principal Investigator: Fabio Forghieri         
Sub-Investigator: Monica Morselli         
Università degli Studi di Padova - Ematologia ed Immunologia Clinica Recruiting
Padova, Italy
Contact: Federica Lessi         
Principal Investigator: Federica Lessi         
AU Policlinico "Paiolo Giaccone" Not yet recruiting
Palermo, Italy
Contact: Maria Enza Mitra         
Principal Investigator: Maria Enza Mitra         
Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia Recruiting
Perugia, Italy
Contact: Maria Paola Martelli         
Principal Investigator: Maria Paola Martelli         
Sub-Investigator: Valeria Cardinali         
IFO Istituto Nazionale Tumori Regina Elena Recruiting
Roma, Italy
Contact: Andrea Mengarelli         
Principal Investigator: Andrea Mengarelli         
Sub-Investigator: Antonio Spadea         
Università Cattolica del Sacro Cuore - Policlinico A.Gemelli Recruiting
Roma, Italy
Contact: Patrizia Chiusolo         
Principal Investigator: Patrizia Chiusolo         
Università degli Studi - Policlinico di Tor Vergata Not yet recruiting
Roma, Italy
Contact: Maria Teresa Voso         
Principal Investigator: Maria Teresa Voso         
Sub-Investigator: Francesco Buccisano         
Università degli Studi - Policlinico Tor Vergata Recruiting
Rome, Italy
Contact: Maria Teresa Voso         
Principal Investigator: Maria Teresa Voso         
Sub-Investigator: Francesco Buccisano         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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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
Additional Information:

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02986620    
Other Study ID Numbers: AML1516
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid