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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 : Completed
First Posted : December 8, 2016
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 388 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
Actual Primary Completion Date : March 22, 2021
Actual Study Completion Date : March 22, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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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. ]

Eligibility Criteria
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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;
Contacts and Locations
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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


Locations
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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
More Information
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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: January 4, 2022
Last Verified: September 2021
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