NCT07269067Not yet recruiting
Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- Jan 2026
- Primary completion date
- Jul 2027
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT07269067
What you commit to
- Study type: Observational
- Planned participants: 60
- From Jan 2026 to the primary completion date, Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- AML subtypes M3, M6 or M7
- Acute leukaemia of ambiguous lineage
- Missing or unusable flow-cytometry files for required time points
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.