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

December 31, 2021 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

388

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
      • Bari, Italy
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
      • Bologna, 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
      • Brindisi, Italy
        • Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
      • Meldola, Italy
        • I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
      • Messina, Italy
        • AOU Policlinico G. Martino
      • Milano, Italy
        • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
      • Milano, Italy
        • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
      • Milano, Italy
        • Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
      • Modena, Italy
        • UO Ematologia _AOU Policlinico di Modena
      • Padova, Italy
        • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
      • Palermo, Italy
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
      • Palermo, Italy
        • AU Policlinico "Paiolo Giaccone"
      • Parma, Italy
        • Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
      • Perugia, Italy
        • Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia
      • Piacenza, Italy
        • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
      • Roma, 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
      • Rome, Italy
        • Università degli Studi - Policlinico Tor Vergata
      • San Giovanni Rotondo, Italy
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
      • Udine, Italy
        • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult AML patients

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with the IDH mutations in AML at initial diagnosis.
Time Frame: At two years from study entry.
At two years from study entry.
Number of patients with the IDH mutations in AML at relapse.
Time Frame: At three years from study entry.
At three years from study entry.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Actual)

March 22, 2021

Study Completion (Actual)

March 22, 2021

Study Registration Dates

First Submitted

December 6, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AML1516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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