Myelodysplastic SyndromesMPO-MDS-PILOTNCT03363399
Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression and Myelodysplastic Syndromes
An observational study of Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage, reflecting ineffective… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
- What is being tested?
- Flow cytometry analysis of neutrophil myeloperoxidase expression
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Feb 2018to 6 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants are consecutive unselected adults of 50 years of age or more and who are referred for suspected MDS or CMML. Suspicion of MDS or CMML is based on medical history and peripheral blood cytopenia. To be eligible, patients will be required to meet all three inclusion criteria and none of the exclusion criteria. Yet, patients with milder levels of cytopenia might by eligible based on medical history.
Who may be able to join
- Age ≥50 years;
- Clinical suspicion of myelodysplastic syndromes (MDS) and / or chronic myelomonocytic leukemia (CMML);
- Peripheral blood cytopenia defined by hemoglobin concentration <10 g/dL, platelet count <100 x109/L, and/or absolute neutrophil count <1.8 x109/L.
Who cannot join
- History of or active documented MDS or CMML;
- Admission to the intensive care unit;
- Suspicion of hematological disease other than MDS requiring bone marrow aspirate and/or biopsy (i.e., acute leukemia,…);
- Absolute neutrophil count <0.5 x109/L;
- Not affiliated with a social security system;
- Homelessness;
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- Incarcerated;
- Inability to understand research information and/or to provide non-opposition, because of language restriction, dementia, or altered mental status;
- Refusal to participate;
- Previous enrollment in the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, 63003
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
About this study
Official title: Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: A Pilot Diagnostic Accuracy Study
Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage, reflecting ineffective hematopoiesis.
The diagnostic work-up of MDS includes a bone marrow aspirate and biopsy, which is an invasive procedure, for cytomorphologic and cytogenetic evaluations. Because the prevalence of disease is lower than 20% in subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms.
Read more
An objective assay is highly desirable for accurately ruling out MDS based on peripheral blood samples, which may obviate the need for invasive bone marrow aspiration and biopsy in patients with negative results.
Few studies have investigated the value of peripheral blood flow cytometric analysis for the diagnosis of MDS and/or chronic myelomonocytic leukemia (CMML). Although promising, these studies lacked replication of their results, used a case-control design, which was prone to spectrum bias, or yielded imprecise diagnostic accuracy estimates due to relatively limited sample sizes.
Anecdotal evidence supports the potential of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS and CMML. Myeloperoxidase is an enzyme synthetized during myeloid differentiation that constitutes the major component of neutrophil azurophilic granules. Myeloperoxidase expression may reflect neutrophil hypogranulation, which is a classical although subjective dysplastic feature of MDS. Flow cytometric analysis of myeloperoxidase expression in bone marrow neutrophil granulocytes has been used for discriminating low versus high grade MDS. Yet a study reporting on the accuracy of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS is still lacking, to our knowledge.
In this study, the investigators hypothesize that flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood may accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity approaching 100%, in routine practice.
In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. Flow cytometry analysis of peripheral blood neutrophil myeloperoxidase expression will not require additional blood sample. A test result will have no impact on patient management. No follow-up visits are planned in this cross-sectional study.
Read the detailed description
The primary objective of MPO-MDS-pilot study is to estimate the accuracy of flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of myelodysplastic syndromes (MDS) and/or chronic myelomonocytic leukemia (CMML).
The secondary objectives are:
- to provide accuracy estimates for prespecified thresholds of neutrophil myeloperoxidase expression in peripheral blood in ruling out MDS and/or CMML.
- to estimate the prevalence of alternate diagnosis established by bone marrow cytomorphology.
The MPO-MDS-pilot project is a multicenter, phase II, cross-sectional, diagnostic accuracy study of consecutive unselected patients referred for suspected MDS or CMML.
Screening: All consecutive patients referred to the immuno-hematology lab at the study sites for suspicion of MDS will be screened for eligibility. A lab physician will review inclusion and exclusion criteria, using computerized medical and laboratory records.
Recruitment: Participants will be included in the study once all the screening activities have been conducted and only if the patient meets all inclusion and none exclusion criteria. The consent for flow cytometry analysis of peripheral blood sample and data collection through chart review will be sought under a regime of "non-opposition" (opt-out): after appropriate written information is delivered, cross-sectional data will be collected except in case of opposition from the patient. All patients included in the study will be assigned a unique patient identification number. This number will be used to identify the patient throughout the study.
Index test: Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard.
Reference standard: The diagnosis of MDS will be established according to the World Health Organization (WHO) classification, based on clinical data, peripheral blood cytopenia, cytomorphology of peripheral blood and bone marrow aspirate, and cytogenetic analysis. The criteria for MDS diagnosis are 1) the presence of ≥10% dysplastic cells in any hematopoietic lineage, 2) the exclusion of acute myeloid leukemia (defined by the presence of ≥20% peripheral blood or bone marrow blasts), and 3) the exclusion of reactive etiologies of dysplasia. Cytopenia is defined by hemoglobin concentration <10 g/dL, platelet count <100x109/L, and/or absolute neutrophil count <1.8 x109/L. Yet a diagnosis of MDS could be made with milder levels of cytopenia. Idiopathic cytopenia of uncertain significance (ICUS) is defined by unexplained mild persistent cytopenia for at least 6 months and the failure to establish the diagnosis to MDS according to published guidelines. Consistent with WHO classification, MDS subcategorization will rely on the degree of dysplasia (unilineage versus multilineage), blast percentages, presence of ring sideroblasts, and cytogenetic analysis (del(5q)). The criteria for CMML diagnosis are 1) the presence of persistent peripheral blood monocytosis ≥1 x109/L, and 2) monocyte accounting for more than 10% of the white blood cell differential count. Evaluation of bone marrow cytomorphology will be performed prospectively by experienced hematopathologists who are blinded to the index test results.
Patients with confirmed suspicion of MDS: Participants for whom the diagnosis of MDS (or CMML) is confirmed by the reference standard will be categorized as patients with confirmed suspicion of MDS.
Patients with unconfirmed suspicion of MDS: Participants for whom the diagnosis of MDS (or CMML) is ruled out by the reference standard will be categorized as patients with unconfirmed suspicion of MDS. This latter subgroup will include patients with ICUS, as defined in accordance with published guidelines
Follow-up: No follow-up visit is planned in this cross-sectional diagnostic accuracy study.
- Being tested
- Flow cytometry analysis of neutrophil myeloperoxidase expression
- Keywords
- Diagnostic accuracy study, Flow cytometry analysis, Myeloperoxidase, Peripheral blood sample
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometry analysis of neutrophil myeloperoxidase expressionDiagnostic test
Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood samples will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard. Peripheral blood samples will be collected in 5 ml (EDTA) anticoagulant plastic tubes and processed within 24 h maximum of collection. The samples will be stored at 4°C overnight.
Blood samples containing at least 105 neutrophils will be incubated with a panel of antibodies conjugated to fluorochromes, according to the manufacturers' recommendations.
At least 10,000 cell events will be acquired on a 3-laser, 8-color flow cytometer and analyzed using Becton Dickinson (BD) Fluorescence-activated cell sorting (FACS) Diva Software version 6. Each marker will be expressed as median, geometric and arithmetic mean, regular and robust coefficient of variation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver Operating Characteristic (ROC) curve of neutrophil myeloperoxidase expression in peripheral blood
The primary outcome is the discrimination of the index test (i.e., flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood) for the diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMLL) quantified by the area under the ROC curve point estimate along with its 95% confidence interval.
Measured: Baseline
Secondary outcomes (5)
Sensitivity point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Measured: Baseline
Specificity point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Measured: Baseline
Negative predictive value point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Measured: Baseline
Positive predictive value point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Measured: Baseline
Prevalence point estimate (along with 95% confidence interval) for alternate diagnosis established by bone marrow cytomorphology.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start22 Feb 2018
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana Raskovalova, MD, Study chair, Centre Hospitalier Universitaire Grenoble Alpes, FranceRichard Veyrat-Masson, MD, Principal investigator, Centre Hospitalier Universitaire Clermont-Ferrand, FranceSophie Park, MD, Principal investigator, Centre Hospitalier Universitaire Grenoble Alpes, FranceMarc Berger, MD, Principal investigator, Centre Hospitalier Universitaire Clermont-Ferrand, FranceJean-Yves Cesbron, MD, Principal investigator, Centre Hospitalier Universitaire Grenoble Alpes, FranceMarie-Christine Jacob, MD, Principal investigator, Centre Hospitalier Universitaire Grenoble Alpes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363399
- Sponsor's protocol ID
- 38RC17.249
- Other IDs
- 2017-A02361-52
- Acronym
- MPO-MDS-PILOT
- Status last verified
- Sep 2018
- First submitted
- 17 Nov 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigators will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.
Publications
Raskovalova T, Scheffen L, Jacob MC, Vettier C, Bulabois B, Szymanski G, Chevalier S, Gonnet N, Park S, Labarere J. Comparative diagnostic accuracy between simplified and original flow cytometric gating strategies for peripheral blood neutrophil myeloperoxidase expression in ruling out myelodysplastic syndromes. PLoS One. 2022 Nov 18;17(11):e0276095. doi: 10.1371/journal.pone.0276095. eCollection 2022.
PubMed 36399441Raskovalova T, Jacob MC, Bulabois CE, Mariette C, Scheffen L, Park S, Labarere J. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for ruling out myelodysplastic syndromes: a prospective validation study. Ann Hematol. 2021 May;100(5):1149-1158. doi: 10.1007/s00277-021-04446-7. Epub 2021 Feb 10.
PubMed 33569703
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: A Pilot Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03363399
- Acronym / sponsor ID
- MPO-MDS-PILOT / 38RC17.249
- Keywords
- Diagnostic accuracy study, Flow cytometry analysis, Myeloperoxidase, Peripheral blood sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 6 Dec 2017 (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.
Myelodysplastic syndromes (MDS) constitute a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. MDS are characterized by peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage, reflecting ineffective hematopoiesis.
The diagnostic work-up of MDS includes a bone marrow aspirate and biopsy, which is an invasive procedure, for cytomorphologic and cytogenetic evaluations. Because the prevalence of disease is lower than 20% in subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms.
An objective assay is highly desirable for accurately ruling out MDS based on peripheral blood samples, which may obviate the need for invasive bone marrow aspiration and biopsy in patients with negative results.
Few studies have investigated the value of peripheral blood flow cytometric analysis for the diagnosis of MDS and/or chronic myelomonocytic leukemia (CMML). Although promising, these studies lacked replication of their results, used a case-control design, which was prone to spectrum bias, or yielded imprecise diagnostic accuracy estimates due to relatively limited sample sizes.
Anecdotal evidence supports the potential of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS and CMML. Myeloperoxidase is an enzyme synthetized during myeloid differentiation that constitutes the major component of neutrophil azurophilic granules. Myeloperoxidase expression may reflect neutrophil hypogranulation, which is a classical although subjective dysplastic feature of MDS. Flow cytometric analysis of myeloperoxidase expression in bone marrow neutrophil granulocytes has been used for discriminating low versus high grade MDS. Yet a study reporting on the accuracy of flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for the diagnosis of MDS is still lacking, to our knowledge.
In this study, the investigators hypothesize that flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood may accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity approaching 100%, in routine practice.
In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. Flow cytometry analysis of peripheral blood neutrophil myeloperoxidase expression will not require additional blood sample. A test result will have no impact on patient management. No follow-up visits are planned in this cross-sectional study.
Detailed description
The primary objective of MPO-MDS-pilot study is to estimate the accuracy of flow cytometric analysis of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of myelodysplastic syndromes (MDS) and/or chronic myelomonocytic leukemia (CMML).
The secondary objectives are:
- to provide accuracy estimates for prespecified thresholds of neutrophil myeloperoxidase expression in peripheral blood in ruling out MDS and/or CMML.
- to estimate the prevalence of alternate diagnosis established by bone marrow cytomorphology.
The MPO-MDS-pilot project is a multicenter, phase II, cross-sectional, diagnostic accuracy study of consecutive unselected patients referred for suspected MDS or CMML.
Screening: All consecutive patients referred to the immuno-hematology lab at the study sites for suspicion of MDS will be screened for eligibility. A lab physician will review inclusion and exclusion criteria, using computerized medical and laboratory records.
Recruitment: Participants will be included in the study once all the screening activities have been conducted and only if the patient meets all inclusion and none exclusion criteria. The consent for flow cytometry analysis of peripheral blood sample and data collection through chart review will be sought under a regime of "non-opposition" (opt-out): after appropriate written information is delivered, cross-sectional data will be collected except in case of opposition from the patient. All patients included in the study will be assigned a unique patient identification number. This number will be used to identify the patient throughout the study.
Index test: Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard.
Reference standard: The diagnosis of MDS will be established according to the World Health Organization (WHO) classification, based on clinical data, peripheral blood cytopenia, cytomorphology of peripheral blood and bone marrow aspirate, and cytogenetic analysis. The criteria for MDS diagnosis are 1) the presence of ≥10% dysplastic cells in any hematopoietic lineage, 2) the exclusion of acute myeloid leukemia (defined by the presence of ≥20% peripheral blood or bone marrow blasts), and 3) the exclusion of reactive etiologies of dysplasia. Cytopenia is defined by hemoglobin concentration <10 g/dL, platelet count <100x109/L, and/or absolute neutrophil count <1.8 x109/L. Yet a diagnosis of MDS could be made with milder levels of cytopenia. Idiopathic cytopenia of uncertain significance (ICUS) is defined by unexplained mild persistent cytopenia for at least 6 months and the failure to establish the diagnosis to MDS according to published guidelines. Consistent with WHO classification, MDS subcategorization will rely on the degree of dysplasia (unilineage versus multilineage), blast percentages, presence of ring sideroblasts, and cytogenetic analysis (del(5q)). The criteria for CMML diagnosis are 1) the presence of persistent peripheral blood monocytosis ≥1 x109/L, and 2) monocyte accounting for more than 10% of the white blood cell differential count. Evaluation of bone marrow cytomorphology will be performed prospectively by experienced hematopathologists who are blinded to the index test results.
Patients with confirmed suspicion of MDS: Participants for whom the diagnosis of MDS (or CMML) is confirmed by the reference standard will be categorized as patients with confirmed suspicion of MDS.
Patients with unconfirmed suspicion of MDS: Participants for whom the diagnosis of MDS (or CMML) is ruled out by the reference standard will be categorized as patients with unconfirmed suspicion of MDS. This latter subgroup will include patients with ICUS, as defined in accordance with published guidelines
Follow-up: No follow-up visit is planned in this cross-sectional diagnostic accuracy study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants are consecutive unselected adults of 50 years of age or more and who are referred for suspected MDS or CMML. Suspicion of MDS or CMML is based on medical history and peripheral blood cytopenia. To be eligible, patients will be required to meet all three inclusion criteria and none of the exclusion criteria. Yet, patients with milder levels of cytopenia might by eligible based on medical history.
Key inclusion criteria (3 listed)
- Age ≥50 years;
- Clinical suspicion of myelodysplastic syndromes (MDS) and / or chronic myelomonocytic leukemia (CMML);
- Peripheral blood cytopenia defined by hemoglobin concentration <10 g/dL, platelet count <100 x109/L, and/or absolute neutrophil count <1.8 x109/L.
Key exclusion criteria (10 listed)
- History of or active documented MDS or CMML;
- Admission to the intensive care unit;
- Suspicion of hematological disease other than MDS requiring bone marrow aspirate and/or biopsy (i.e., acute leukemia,…);
- Absolute neutrophil count <0.5 x109/L;
- Not affiliated with a social security system;
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 |
|---|---|---|
| Flow cytometry analysis of neutrophil myeloperoxidase expressionFlow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood samples will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard. Peripheral blood samples will be collected in 5 ml (EDTA) anticoagulant plastic tubes and processed within 24 h maximum of collection. The samples will be stored at 4°C overnight. Blood samples containing at least 105 neutrophils will be incubated with a panel of antibodies conjugated to fluorochromes, according to the manufacturers' recommendations. At least 10,000 cell events will be acquired on a 3-laser, 8-color flow cytometer and analyzed using Becton Dickinson (BD) Fluorescence-activated cell sorting (FACS) Diva Software version 6. Each marker will be expressed as median, geometric and arithmetic mean, regular and robust coefficient of variation. | Diagnostic test | – |
Primary outcome
Area under the Receiver Operating Characteristic (ROC) curve of neutrophil myeloperoxidase expression in peripheral blood
Time frame: Baseline
The primary outcome is the discrimination of the index test (i.e., flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood) for the diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMLL) quantified by the area under the ROC curve point estimate along with its 95% confidence interval.
5 secondary outcomes
Sensitivity point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Time frame: Baseline
Specificity point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Time frame: Baseline
Negative predictive value point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Time frame: Baseline
Positive predictive value point estimates (along with 95% confidence interval) of neutrophil myeloperoxidase expression in peripheral blood for the diagnosis of MDS or CMML
Time frame: Baseline
Prevalence point estimate (along with 95% confidence interval) for alternate diagnosis established by bone marrow cytomorphology.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Derived from this study: PubMed 36399441Raskovalova T, Scheffen L, Jacob MC, Vettier C, Bulabois B, Szymanski G, Chevalier S, Gonnet N, Park S, Labarere J. Comparative diagnostic accuracy between simplified and original flow cytometric gating strategies for peripheral blood neutrophil myeloperoxidase expression in ruling out myelodysplastic syndromes. PLoS One. 2022 Nov 18;17(11):e0276095. doi: 10.1371/journal.pone.0276095. eCollection 2022.
- Derived from this study: PubMed 33569703Raskovalova T, Jacob MC, Bulabois CE, Mariette C, Scheffen L, Park S, Labarere J. Flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression for ruling out myelodysplastic syndromes: a prospective validation study. Ann Hematol. 2021 May;100(5):1149-1158. doi: 10.1007/s00277-021-04446-7. Epub 2021 Feb 10.
- Individual participant dataSharing planned: Yes. The principal investigators will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.
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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. This study is not recruiting at the moment.
Tatiana Raskovalova, MD study chair
Centre Hospitalier Universitaire Grenoble Alpes, France
Richard Veyrat-Masson, MD principal investigator
Centre Hospitalier Universitaire Clermont-Ferrand, France
Sophie Park, MD principal investigator
Centre Hospitalier Universitaire Grenoble Alpes, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, run by University Hospital, Grenoble at 2 sites in France.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Receiver Operating Characteristic (ROC) curve of neutrophil myeloperoxidase expression in peripheral blood (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363399, which also lists 2 linked publications.
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 25 Sep 2018.