NCT02986620

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 388 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML, Adult

Interventions

Type	Name	Description
GENETIC	IDH mutation test performed at diagnosis or relapse until January 31st, 2019.	Observation of the test result.

Timeline

• Start date: 2017-10-31
• Primary completion: 2021-03-22
• Completion: 2021-03-22
• First posted: 2016-12-08
• Last updated: 2022-01-04

Locations

24 sites across 1 country: Italy