An interventional study of Bone marrow or peripheral blood withdrawal for test comparison in Acute Myeloid Leukemia, Acute Myeloid Leukemia, Adult and Acute Promyelocytic Leukemia, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Not applicable, Interventional, and Screening
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.
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.
The blood sample from bone marrow (BM) (or PB) for test RAMD, will be collected by the participating centers at diagnosis together with the sample for GSS. The gold-standard tests will be performed on the diagnostic sample at the collecting center according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory according to the RAMD protocol. The results of GSS and RAMD will be entered independently into the eCRF as soon as they become available and subsequently compared for the purposes of the study.
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's planned enrollment of 75 is above the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 134 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
1. Diagnosis of secondary AML
The blood sample from bone marrow (or PB) will be collected at diagnosis for test RAMD
Other: 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.
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.
Time frame: at 24 months
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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