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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

AML subtypes M3, M6 or M7

Acute leukaemia of ambiguous lineage

Missing or unusable flow-cytometry files for required time points

Trial design

Treatments tested in this trial

  • Conventional gating
  • Automated gating

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators