Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional gating, Automated gating.
- Who it may be relevant to
- Registry conditions: Leukemia, Myeloid, Acute. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Retrospective Cohort Assessing Concordance Between Manual Gating and Unsupervised FlowSOM Gating for Minimal Residual Disease Detection by Multiparameter Flow Cytometry in Adult and Paediatric Acute Myeloid Leukaemia
Overview
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.
Detailed description
Acute myeloid leukaemia remains associated with high relapse rates despite complete remission after induction chemotherapy. Sensitive identification of residual leukaemic blasts (MRD) guides risk-adapted therapy. Flow cytometry is applicable to nearly all patients but relies on operator-dependent manual gating, which may lack reproducibility when rare or immunophenotypically atypical blasts are present. A data-driven alternative based on FlowSOM clustering was developed at Bordeaux to overcome these limitations. DualFlow retrospectively analyses paired flow-cytometry standard (FCS) files from 60 AML patients (≈ 100 MRD determinations) drawn from the DATAML Bordeaux adult database and the paediatric haemato-oncology service. Files are distributed to three partner centers for blinded re-analysis. Each sample undergoes: (1) conventional manual gating in two expert centers; (2) unsupervised FlowSOM gating in one center; (3) molecular MRD assessment when available. Primary analysis calculates sensitivity, specificity, predictive values and Cohen/Fleiss kappa for MRD ≥ 0.1 %. Secondary analyses include concordance with molecular MRD, Bland-Altman and correlation for MRD 0.01-0.1 %, impact on relapse-free and overall survival using Kaplan-Meier and Cox models, and operator reproducibility for manual gating. Covariate effects (age, cytogenetics, molecular risk, treatment) are explored through stratified and multivariable methods. No additional interventions or specimens are collected; only de-identified FCS files and routine clinical data are used.
Interventions
- Diagnostic test Conventional gating
Manual expert gating of multiparameter flow-cytometry data for MRD - Diagnostic test Automated gating
Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD
Primary outcome measures
- Concordance of MRD ≥ 0.1 % between manual gating and unsupervised FlowSOM gating [Time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy]
Secondary outcome measures (4)
- Concordance of flow-cytometry MRD (both methods) with molecular MRD [Time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy]
- Agreement of MRD 0.01-0.1 % between manual and unsupervised gating [Time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy]
- Concordance of flow-cytometry MRD (both methods) with molecular MRD [Time frame: From diagnosis up to 60 months]
- Inter-operator reproducibility of manual gating [Time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy]
Eligibility criteria
Inclusion criteria
- 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
- Non-opposition or consent for secondary use of data
Exclusion criteria
- AML subtypes M3, M6 or M7
- Acute leukaemia of ambiguous lineage
- Missing or unusable flow-cytometry files for required time points
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07269067 · CHUBX 2025/033