Clinical trial · Observational
Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated gating | Diagnostic Test | — | UNRESOLVED |
| Conventional gating | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Adult AML cohort
- description
- Adults ≥ 18 years with ELN-defined AML enrolled in DATAML Bordeaux, possessing flow-cytometry MRD data after induction and consolidation 1
- interventionNames
- Diagnostic Test: Conventional gating
- Diagnostic Test: Automated gating
- label
- Paediatric AML cohort
- description
- Children and adolescents 0-18 years managed in the paediatric haemato-oncology unit, with analogous MRD flow-cytometry data
- interventionNames
- Diagnostic Test: Conventional gating
- Diagnostic Test: Automated gating
Primary outcomes (1)
- measure
- Concordance of MRD ≥ 0.1 % between manual gating and unsupervised FlowSOM gating
- timeFrame
- up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available