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

NCT07269067 | Not Yet Recruiting

• 1 other identifier: CHUBX 2025/033
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia; Minimal Residual Disease; Flow Cytometry; FlowSOM; Gating Algorithm; Machine Learning

Outcome Measures

Primary Outcomes (1)

• Concordance of MRD ≥ 0.1 % between manual gating and unsupervised FlowSOM gating

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

  up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy

Secondary Outcomes (4)

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

  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

  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

  From diagnosis up to 60 months

• Inter-operator reproducibility of manual gating

  up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy

Study Arms (2)

Adult AML cohort

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

Diagnostic Test: Conventional gating; Diagnostic Test: Automated gating

Paediatric AML cohort

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

Diagnostic Test: Conventional gating; Diagnostic Test: Automated gating

Interventions

Conventional gating DIAGNOSTIC_TEST

Manual expert gating of multiparameter flow-cytometry data for MRD

Adult AML cohort; Paediatric AML cohort

Automated gating DIAGNOSTIC_TEST

Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD

Adult AML cohort; Paediatric AML cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult and paediatric patients diagnosed with ELN-defined AML at Bordeaux University Hospital between 2010 and 2024, for whom routine multiparameter flow-cytometry MRD assessments post-induction and post-consolidation 1 are available

You may qualify if:

• Confirmed diagnosis of acute myeloid leukaemia per ELN 2022
• Age ≥ 18 years (adult cohort) or 0-20 years (paediatric cohort)
• Available flow-cytometry MRD data post-induction and post-consolidation 1
• Non-opposition or consent for secondary use of data

You may not qualify if:

• AML subtypes M3, M6 or M7
• Acute leukaemia of ambiguous lineage
• Missing or unusable flow-cytometry files for required time points

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aguirre MIMOUN

CONTACT

05 57 65 60 98; aguirre.mimoun@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share