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NCT Number: NCT07269067

Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)

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.

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional gating

Diagnostic Test

Manual expert gating of multiparameter flow-cytometry data for MRD

Automated gating

Diagnostic Test

Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD

Primary outcomes

  1. 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

    Sensitivity, specificity, positive and negative predictive values, Cohen and Fleiss kappa statistics comparing the 3 methods on paired samples

Secondary outcomes

  1. 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

    Sensitivity, specificity, positive and negative predictive values, Cohen and Fleiss kappa statistics comparing the 3 methods on paired samples

  2. 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

    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

  3. Concordance of flow-cytometry MRD (both methods) with molecular MRD

    Time frame: From diagnosis up to 60 months

    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

  4. 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

    Intra-class correlation coefficients and Fleiss kappa statistics calculated across three independent operators performing manual gating on the same flow-cytometry MRD files

Study contacts

Contact information is provided by the study sponsor or research team.

Aguirre MIMOUN

CONTACT

[email protected]

05 57 65 60 98

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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

Acronym: DUALFLOW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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