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Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Summary
Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients on blood samples.
Official title: Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice RAMD (Rapid AML Mutations Detection)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2027-01
Completion Date
2029-01
Last Updated
2026-10-09
Healthy Volunteers
No
Interventions
Bone marrow or peripheral blood withdrawal for test comparison
The blood sample from bone marrow (BM) (or PB) for test RAMD will be collected by the participating centers at diagnosis. The gold-standard tests (GSS) will be performed according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory. The results of GSS and RAMD will be subsequently compared.