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

NCT07269067 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-12-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-07-31
Completion
2027-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07269067 on ClinicalTrials.gov