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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02986620

Enrollment

388

Registered

2016-12-08

Start date

2017-10-31

Completion date

2021-03-22

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML, Adult

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.

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.

Interventions

GENETICIDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Observation of the test result.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026