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

NCT ID: NCT07269067

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-07-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adult AML cohort

Adults ≥ 18 years with ELN-defined AML enrolled in DATAML Bordeaux, possessing flow-cytometry MRD data after induction and consolidation 1

Conventional gating

Intervention Type: DIAGNOSTIC_TEST

Manual expert gating of multiparameter flow-cytometry data for MRD

Automated gating

Intervention Type: DIAGNOSTIC_TEST

Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD

Paediatric AML cohort

Children and adolescents 0-18 years managed in the paediatric haemato-oncology unit, with analogous MRD flow-cytometry data

Conventional gating

Intervention Type: DIAGNOSTIC_TEST

Manual expert gating of multiparameter flow-cytometry data for MRD

Automated gating

Intervention Type: DIAGNOSTIC_TEST

Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD

Interventions

Conventional gating

Manual expert gating of multiparameter flow-cytometry data for MRD

Intervention Type: DIAGNOSTIC_TEST

Automated gating

Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD

Intervention Type: DIAGNOSTIC_TEST

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Aguirre MIMOUN

Role: CONTACT

aguirre.mimoun@chu-bordeaux.fr

05 57 65 60 98

Other Identifiers

CHUBX 2025/033

Identifier Type: -

Identifier Source: org_study_id