NCT07269067

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-12-08
• Last updated: 2025-12-08