Leukemia, Myeloid, AcuteDUALFLOWNCT07269067
Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)
An observational study of Leukemia, Myeloid, Acute, run by University Hospital, Bordeaux.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Conventional gating and Automated gating
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- AML subtypes M3, M6 or M7
- Acute leukaemia of ambiguous lineage
- Missing or unusable flow-cytometry files for required time points
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
Acute myeloid leukaemia remains associated with high relapse rates despite complete remission after induction chemotherapy. Sensitive identification of residual leukaemic blasts (MRD) guides risk-adapted therapy. Flow cytometry is applicable to nearly all patients but relies on operator-dependent manual gating, which may lack reproducibility when rare or immunophenotypically atypical blasts are present. A data-driven alternative based on FlowSOM clustering was developed at Bordeaux to overcome these limitations. DualFlow retrospectively analyses paired flow-cytometry standard (FCS) files from 60 AML patients (≈ 100 MRD determinations) drawn from the DATAML Bordeaux adult database and the paediatric haemato-oncology service. Files are distributed to three partner centers for blinded re-analysis. Each sample undergoes: (1) conventional manual gating in two expert centers; (2) unsupervised FlowSOM gating in one center; (3) molecular MRD assessment when available. Primary analysis calculates sensitivity, specificity, predictive values and Cohen/Fleiss kappa for MRD ≥ 0.1 %. Secondary analyses include concordance with molecular MRD, Bland-Altman and correlation for MRD 0.01-0.1 %, impact on relapse-free and overall survival using Kaplan-Meier and Cox models, and operator reproducibility for manual gating. Covariate effects (age, cytogenetics, molecular risk, treatment) are explored through stratified and multivariable methods. No additional interventions or specimens are collected; only de-identified FCS files and routine clinical data are used.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- Conventional gating, Automated gating
- Keywords
- Acute Myeloid Leukemia, Minimal Residual Disease, Flow Cytometry, FlowSOM, Gating Algorithm, Machine Learning
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional gatingDiagnostic test
Manual expert gating of multiparameter flow-cytometry data for MRD
Automated gatingDiagnostic test
Unsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD
| Study group | Role | What they receive |
|---|---|---|
| Adult AML cohort | Adults ≥ 18 years with ELN-defined AML enrolled in DATAML Bordeaux, possessing flow-cytometry MRD data after induction and consolidation 1 Receives: 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 Receives: Diagnostic Test: Conventional gating; Diagnostic Test: Automated gating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Sensitivity, specificity, positive and negative predictive values, Cohen and Fleiss kappa statistics comparing the 3 methods on paired samples
Measured: 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
Bland-Altman limits of agreement and Pearson or Spearman correlation coefficients calculated from log-transformed MRD percentages to assess agreement between both gating methods in the low MRD range
Measured: 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
Kaplan-Meier survival analyses and multivariable Cox regression models used to compare relapse-free survival (RFS) and overall survival (OS) according to MRD detection method
Measured: From diagnosis up to 60 months
Inter-operator reproducibility of manual gating
Intra-class correlation coefficients and Fleiss kappa statistics calculated across three independent operators performing manual gating on the same flow-cytometry MRD files
Measured: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269067
- Sponsor's protocol ID
- CHUBX 2025/033
- Acronym
- DUALFLOW
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07269067
- Acronym / sponsor ID
- DUALFLOW / CHUBX 2025/033
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Acute Myeloid Leukemia, Minimal Residual Disease, Flow Cytometry, FlowSOM, Gating Algorithm, Machine Learning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute myeloid leukaemia remains associated with high relapse rates despite complete remission after induction chemotherapy. Sensitive identification of residual leukaemic blasts (MRD) guides risk-adapted therapy. Flow cytometry is applicable to nearly all patients but relies on operator-dependent manual gating, which may lack reproducibility when rare or immunophenotypically atypical blasts are present. A data-driven alternative based on FlowSOM clustering was developed at Bordeaux to overcome these limitations. DualFlow retrospectively analyses paired flow-cytometry standard (FCS) files from 60 AML patients (≈ 100 MRD determinations) drawn from the DATAML Bordeaux adult database and the paediatric haemato-oncology service. Files are distributed to three partner centers for blinded re-analysis. Each sample undergoes: (1) conventional manual gating in two expert centers; (2) unsupervised FlowSOM gating in one center; (3) molecular MRD assessment when available. Primary analysis calculates sensitivity, specificity, predictive values and Cohen/Fleiss kappa for MRD ≥ 0.1 %. Secondary analyses include concordance with molecular MRD, Bland-Altman and correlation for MRD 0.01-0.1 %, impact on relapse-free and overall survival using Kaplan-Meier and Cox models, and operator reproducibility for manual gating. Covariate effects (age, cytogenetics, molecular risk, treatment) are explored through stratified and multivariable methods. No additional interventions or specimens are collected; only de-identified FCS files and routine clinical data are used.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult AML cohort | – | Diagnostic Test: Conventional gating, Diagnostic Test: Automated gatingAdults ≥ 18 years with ELN-defined AML enrolled in DATAML Bordeaux, possessing flow-cytometry MRD data after induction and consolidation 1 |
| Paediatric AML cohort | – | Diagnostic Test: Conventional gating, Diagnostic Test: Automated gatingChildren and adolescents 0-18 years managed in the paediatric haemato-oncology unit, with analogous MRD flow-cytometry data |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- AML subtypes M3, M6 or M7
- Acute leukaemia of ambiguous lineage
- Missing or unusable flow-cytometry files for required time points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional gatingManual expert gating of multiparameter flow-cytometry data for MRD | Diagnostic test | Adult AML cohort, Paediatric AML cohort |
| Automated gatingUnsupervised FlowSOM gating of multiparameter flow-cytometry data for MRD | Diagnostic test | Adult AML cohort, Paediatric AML cohort |
Primary outcome
Concordance of MRD ≥ 0.1 % between manual gating and unsupervised FlowSOM gating
Time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy
Sensitivity, specificity, positive and negative predictive values, Cohen and Fleiss kappa statistics comparing the 3 methods on paired samples
4 secondary outcomes
Concordance of flow-cytometry MRD (both methods) with molecular MRD
Time frame: 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
Time frame: 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
Time frame: From diagnosis up to 60 months
Inter-operator reproducibility of manual gating
Time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myeloid, Acute, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aguirre MIMOUN (05 57 65 60 98, aguirre.mimoun@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of MRD ≥ 0.1 % between manual gating and unsupervised FlowSOM gating (time frame: up to 8 weeks after initiation first cycle of intensive therapy and after initiation of second cycle of intensive therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.