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NCT07269067

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-01

Completion Date

2027-07

Last Updated

2025-12-08

Healthy Volunteers

No

Interventions

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