This retrospective multicentre cohort evaluates the agreement of measurable residual disease (MRD) detection in acute myeloid leukaemia (AML) using two flow-cytometry gating approaches. Manual expert gating is compared with an unsupervised FlowSOM clustering algorithm across post-induction and post-consolidation samples from 50 adults and 10 paediatric patients treated at Bordeaux University Hospital. The primary hypothesis states that unsupervised gating detects MRD ≥ 0.1 % with sensitivity and specificity comparable to manual gating.
Confirmed diagnosis of acute myeloid leukaemia per ELN 2022
Age ≥ 18 years (adult cohort) or 0-20 years (paediatric cohort)
Inclusion in DATAML Bordeaux database or paediatric haemato-oncology records
Available flow-cytometry MRD data post-induction and post-consolidation 1
AML subtypes M3, M6 or M7
Acute leukaemia of ambiguous lineage
Missing or unusable flow-cytometry files for required time points
Consecutive adult and paediatric patients diagnosed with ELN-defined AML at Bordeaux University Hospital between 2010 and 2024, for whom routine multiparameter flow-cytometry MRD assessments post-induction and post-consolidation 1 are available
Cohort
Retrospective
Conventional gating
Diagnostic testManual expert gating of multiparameter flow-cytometry data for MRD
Automated gating
Diagnostic testUnsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD
Concordance of MRD ≥ 0.1 % between manual gating and unsupervised FlowSOM gating
Sensitivity, specificity, positive and negative predictive values, Cohen and Fleiss kappa statistics comparing the 3 methods on paired samples
Concordance of flow-cytometry MRD (both methods) with molecular MRD
Sensitivity, specificity, positive and negative predictive values, Cohen and Fleiss kappa statistics comparing the 3 methods on paired samples
Agreement of MRD 0.01-0.1 % between manual and unsupervised gating
Bland-Altman limits of agreement and Pearson or Spearman correlation coefficients calculated from log-transformed MRD percentages to assess agreement between both gating methods in the low MRD range
Concordance of flow-cytometry MRD (both methods) with molecular MRD
Kaplan-Meier survival analyses and multivariable Cox regression models used to compare relapse-free survival (RFS) and overall survival (OS) according to MRD detection method
Inter-operator reproducibility of manual gating
Intra-class correlation coefficients and Fleiss kappa statistics calculated across three independent operators performing manual gating on the same flow-cytometry MRD files
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