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
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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.|
The study will be conducted as follows:
- 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).
- 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 [Patient Registry]|
|Actual Enrollment :||388 participants|
|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|
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.
- Number of patients with the IDH mutations in AML at initial diagnosis. [ Time Frame: 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. ]
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.
|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|
- 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.
- AML M3 subtype according to the FAB classification;
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
|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|
|Responsible Party:||Gruppo Italiano Malattie EMatologiche dell'Adulto|
|Other Study ID Numbers:||
|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|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type