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.
Patients with de novo AML, includind Acute Promyelocytic Leukemia (APL), untreated, newly diagnosed according to WHO/ICC 2022 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization
Signed written informed consent according to ICH/EU/GCP and national local laws.
Availability of 1 aliquot of White Blood Cells pellet (≥3x106 WBCs or purified from ≥1.5mL of blood) from bone marrow (BM) or peripheral blood (PB) collected at diagnosis for RAMD. The aliquot should be stored at -90°C until shipment.
Age ≥ 18 years
None
Single group
Bone marrow or peripheral blood withdrawal for test comparison
Other interventionThe 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.
Prognostic risk classification
Proportion of patients whose prognostic risk classification according to the ELN2022 criteria (Favorable/Low-risk, Intermediate/Intermediate-risk, Adverse/High-risk) is concordant between the investigational method RAMD and GSS, to demonstrate non-inferiority of RAMD versus GSS.
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