Myeloproliferative NeoplasmMonSThrNCT05419648
Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
Myeloproliferative neoplasms (MPN) are hematological malignancies associated with a major risk of thrombosis. Monocytes are hematopoietic cells with a central role in thrombosis. An activation of monocytes has been demonstrated in MPN patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- 1 additional tube of blood
- How many people
- 68 participants
- Where
- 5 sitesFrance
- Study dates
- 5 Oct 2022to 22 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Polycythemia Vera (PV) or Essential Thrombocythemia (ET), the 2 Myeloproliferative Neoplasms (MPN) most associated with a risk of thrombosis
Who may be able to join
- Adults patients (age ≥ 18 years)
- Inclusion at diagnosis or during the year following the diagnosis of PV or ET (2016 WHO criteria except bone marrow biopsy that is optional in the presence of a marker of clonality)
- Subject registered with a social security scheme
- Written informed consent obtained
Who cannot join
- Patients with cytoreductive treatment (hydroxyurea, anagrelide, interferon, ruxolitinib) at the time of blood sampling
- Chronic inflammatory disease (cancer, vasculitis, rheumatism, hepato-gastro-intestinal diseases).
- Long term anti-inflammatory treatments:
- Corticoids
- Nonsteroidal anti-inflammatory drugs
- Aspirin (> 325 mg per day)
Show all 11Show fewer
- Cyclo-oxygenase II inhibitors
- Persons under judicial safeguards, trustee or curatorship
- Person unable to give her consent
- Non-cooperative person
- Exclusion period after another clinical study or participation to another clinical study in the 30 days before inclusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Bordeaux, Hématologie clinique et thérapie cellulaire
Bordeaux
CHU de Bordeaux, Laboratoire Hématologie
Bordeaux
CHU de Bordeaux, Médecine interne et immunologie clinique
Bordeaux
CHU de Bordeaux, Médecine Interne et maladies infectieuses
Bordeaux
Institut Begonié, Hématologie clinique
Bordeaux
About this study
Myeloproliferative neoplasms (MPN) are hematological malignancies associated with a major risk of thrombosis. Monocytes are hematopoietic cells with a central role in thrombosis. An activation of monocytes has been demonstrated in MPN patients. However, their study in MPN and their thrombotic complications has never been performed. In this study, we aim to evaluate the association between monocytes sub-populations and thrombotic risk in MPN patients.
Read the detailed description
Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by an increased risk of thrombosis, in particular in Polycythemia Vera (PV) and Essential Thrombocythemia (ET). Predicting the risk of thrombosis in PV and ET patients helps at determining their care (use of antiaggregant and cytoreductive therapies), but relies only on limited clinical and biological criteria (age over 60 years, history of thrombosis, presence of the JAK2V617F mutation, presence of cardiovascular risk factors). Monocytes sub-populations could represent a new biomarker of thrombotic risk in PV and ET patients. Indeed, it has been shown that monocytes are activated and exhibit pro-thrombotic properties in MPN patients, especially those with a history of thrombosis. Some studies have suggested the CD16+ monocytes (intermediate and non-classical monocytes) are associated with an increased risk of arterial thrombosis. Because these monocytes are observed in inflammatory contexts, and because MPN are associated with a chronic inflammation, MPN could be associated with an increase of the proportion or the absolute count of CD16+ monocytes that could be involved in thrombotic complications observed in PV and ET patients.
In this project, an association between the proportion of CD16+ monocytes and thrombosis in PV and ET patients will be searched. Monocytes sub-populations will be studied in PV and ET patients at diagnosis as described by Selimoglu-Buet et al.1 The proportion of CD16+ (intermediate + non-classical) monocytes will be compared between patients presenting with a history of thrombosis and those without any history of thrombosis. The association between the absolute count and the proportion of CD16+, intermediate and non-classical monocytes and the occurrence of thrombosis before diagnosis, the MPN phenotype, the driver mutation, the allelic burden, the clinico-biological presentation and the existence of an inflammatory state will also be evaluated. Due to the low frequency and the high latency of thrombosis reoccurrence, patients' samples only at diagnosis (or during the year after diagnosis) will be analyzed and an association with a history of thrombosis will be made.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- 1 additional tube of blood
- Keywords
- Myeloproliferative Neoplasms, Thrombosis, Monocytes sub-populations, Flow cytometry
- Medical subject headings
- Myeloproliferative Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 additional tube of bloodBiological
For all the patients included, a specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice
| Study group | Role | What they receive |
|---|---|---|
| PV and ET patients | For the main objective, the cohort will be composed of PV and ET patients, some with a history of thrombosis and some without any history of thrombosis. A comparison will also be performed between patients with different MPN (PV or ET) and different driver mutation (JAK2V617F, JAK2 exon 12, CALR, MPL or absence of such mutations) Receives: Biological: 1 additional tube of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
History of thrombosis
Patients wil be classified as having a history of thrombosis if they had a deep vein thrombosis, pulmonary embolism, splanchnic thombosis or any other significant thrombosis. Tinnitus, vertigo, headaches, erythromelalgia as well as superficial vein thrombosis will not be considered as thrombotic events
Measured: At inclusion, up to 1 year after diagnosis
Secondary outcomes (9)
Proportion of CD16+ monocytes in PV and ET patients
The proportion of CD16+ monocytes will be assessed in PV and ET patients, and compared between patients with a history of thrombosis and those without any history of thrombosis
Measured: At inclusion, up to 1 year after diagnosis
Proportion of monocytes sub-populations
The different sub-populations will be defined according to the expression profile of CD14 and CD16, defining classical monocytes (CD14++CD16-), non-classical monocytes (CD14loCD16++) and intermediate monocytes (CD14+CD16+). The proportion of these sub-populations will be assessed in PV and ET patients, and compared between patients with a history of thrombosis and those without any history of thrombosis
Measured: At inclusion, up to 1 year after diagnosis
Count of monocytes sub-populations
The count (G/L) of the different monocytes sub-populations, ie CD16+ monocytes, classical monocytes (CD14++CD16-), non-classical monocytes (CD14loCD16++) and intermediate monocytes (CD14+CD16+) will be assessed in PV and ET patients, and compared between patients with a history of thrombosis and those without any history of thrombosis
Measured: At inclusion, up to 1 year after diagnosis
Type of MPN
The type of MPN will be determined according to the WHO criteria as PV or ET. Patients will be classified as PV if they have an increased hemoglobin level (>16.5g/dL for men, >16g/dL for women), hematocrit (>49% for men, >48% for women), or red cell mass (>125% of theoretical value), together with a mutation in the JAK2 gene (JAK2V617F or exon 12), and a subnormal EPO level. If performed, bone marrow biopsy should be in favor of an MPN.
Patients will be classified as ET if they present a thrombocytosis > 450 G/L, with a detectable mutation in JAK2, CALR or MPL. If performed, bone marrow biopsy should be in favor of an MPN.
Measured: At inclusion, up to 1 year after diagnosis
Driver mutation of MPN
At diagnosis, a driver mutation is searched in MPN patients. We will classify patients in different groups depending on whether they carry the JAK2V617F mutation, a mutation in JAK2 exon 12, a mutation in CALR exon 9, a mutation in MPL exon 10 or any of these mutations (triple negative category). We will thus distinguish 5 groups of patients: "JAK2V617F", "JAK2 exon 12", "CALR exon 9", "MPL exon 10", "triple negative". The proportion of monocytes sub-populations will be compared between these different groups of patients
Measured: At inclusion, up to 1 year after diagnosis
Hemoglobin level
A correlation between the hemoglobin level (g/dL) and monocytes sub-populations proportion will be searched
Measured: At inclusion, up to 1 year after diagnosis
Platelets level
A correlation between the platelets level (G/L) and monocytes sub-populations proportion will be searched
Measured: At inclusion, up to 1 year after diagnosis
Leukocytes level
A correlation between the leukocytes level (G/L) and monocytes sub-populations proportion will be searched
Measured: At inclusion, up to 1 year after diagnosis
Thrombosis risk factors
A correlation between the proportion or count of monocytes sub-populations and thrombosis risk factors will be searched. These include age>60 years, history of thrombosis, tobaccoe use (actual or stopped for les than 3 years), hyperLDLcholesterol level (LDL-Cholesterol > 3,36 mmol/L), hypoHDLcholesterol level (HDL < 1,03 mmol/L in men or < 1,29 mmol/L in women), diabetes (glycemia > 6,93 mmol/L), high blood pressure (> 140/90 mmHg)
Measured: At inclusion, up to 1 year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start5 Oct 2022
- Primary completion22 Jul 2024
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies 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
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier MANSIER, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419648
- Sponsor's protocol ID
- CHUBX 2021/29
- Acronym
- MonSThr
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2022
- Last updated
- 30 Jul 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 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
- ClinicalTrials.gov ID
- NCT05419648
- Acronym / sponsor ID
- MonSThr / CHUBX 2021/29
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- Myeloproliferative Neoplasms, Thrombosis, Monocytes sub-populations, Flow cytometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 15 Jun 2022 (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.
Myeloproliferative neoplasms (MPN) are hematological malignancies associated with a major risk of thrombosis. Monocytes are hematopoietic cells with a central role in thrombosis. An activation of monocytes has been demonstrated in MPN patients. However, their study in MPN and their thrombotic complications has never been performed. In this study, we aim to evaluate the association between monocytes sub-populations and thrombotic risk in MPN patients.
Detailed description
Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by an increased risk of thrombosis, in particular in Polycythemia Vera (PV) and Essential Thrombocythemia (ET). Predicting the risk of thrombosis in PV and ET patients helps at determining their care (use of antiaggregant and cytoreductive therapies), but relies only on limited clinical and biological criteria (age over 60 years, history of thrombosis, presence of the JAK2V617F mutation, presence of cardiovascular risk factors). Monocytes sub-populations could represent a new biomarker of thrombotic risk in PV and ET patients. Indeed, it has been shown that monocytes are activated and exhibit pro-thrombotic properties in MPN patients, especially those with a history of thrombosis. Some studies have suggested the CD16+ monocytes (intermediate and non-classical monocytes) are associated with an increased risk of arterial thrombosis. Because these monocytes are observed in inflammatory contexts, and because MPN are associated with a chronic inflammation, MPN could be associated with an increase of the proportion or the absolute count of CD16+ monocytes that could be involved in thrombotic complications observed in PV and ET patients.
In this project, an association between the proportion of CD16+ monocytes and thrombosis in PV and ET patients will be searched. Monocytes sub-populations will be studied in PV and ET patients at diagnosis as described by Selimoglu-Buet et al.1 The proportion of CD16+ (intermediate + non-classical) monocytes will be compared between patients presenting with a history of thrombosis and those without any history of thrombosis. The association between the absolute count and the proportion of CD16+, intermediate and non-classical monocytes and the occurrence of thrombosis before diagnosis, the MPN phenotype, the driver mutation, the allelic burden, the clinico-biological presentation and the existence of an inflammatory state will also be evaluated. Due to the low frequency and the high latency of thrombosis reoccurrence, patients' samples only at diagnosis (or during the year after diagnosis) will be analyzed and an association with a history of thrombosis will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PV and ET patients | – | Biological: 1 additional tube of bloodFor the main objective, the cohort will be composed of PV and ET patients, some with a history of thrombosis and some without any history of thrombosis. A comparison will also be performed between patients with different MPN (PV or ET) and different driver mutation (JAK2V617F, JAK2 exon 12, CALR, MPL or absence of such mutations) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Polycythemia Vera (PV) or Essential Thrombocythemia (ET), the 2 Myeloproliferative Neoplasms (MPN) most associated with a risk of thrombosis
Key inclusion criteria (4 listed)
- Adults patients (age ≥ 18 years)
- Inclusion at diagnosis or during the year following the diagnosis of PV or ET (2016 WHO criteria except bone marrow biopsy that is optional in the presence of a marker of clonality)
- Subject registered with a social security scheme
- Written informed consent obtained
Key exclusion criteria (11 listed)
- Patients with cytoreductive treatment (hydroxyurea, anagrelide, interferon, ruxolitinib) at the time of blood sampling
- Chronic inflammatory disease (cancer, vasculitis, rheumatism, hepato-gastro-intestinal diseases).
- Long term anti-inflammatory treatments:
- Persons under judicial safeguards, trustee or curatorship
- Person unable to give her consent
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 |
|---|---|---|
| 1 additional tube of bloodFor all the patients included, a specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice | Biological | PV and ET patients |
Primary outcome
History of thrombosis
Time frame: At inclusion, up to 1 year after diagnosis
Patients wil be classified as having a history of thrombosis if they had a deep vein thrombosis, pulmonary embolism, splanchnic thombosis or any other significant thrombosis. Tinnitus, vertigo, headaches, erythromelalgia as well as superficial vein thrombosis will not be considered as thrombotic events
9 secondary outcomes
Proportion of CD16+ monocytes in PV and ET patients
Time frame: At inclusion, up to 1 year after diagnosis
Proportion of monocytes sub-populations
Time frame: At inclusion, up to 1 year after diagnosis
Count of monocytes sub-populations
Time frame: At inclusion, up to 1 year after diagnosis
Type of MPN
Time frame: At inclusion, up to 1 year after diagnosis
Driver mutation of MPN
Time frame: At inclusion, up to 1 year after diagnosis
Hemoglobin level
Time frame: At inclusion, up to 1 year after diagnosis
Platelets level
Time frame: At inclusion, up to 1 year after diagnosis
Leukocytes level
Time frame: At inclusion, up to 1 year after diagnosis
Thrombosis risk factors
Time frame: At inclusion, up to 1 year after diagnosis
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 30 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Myeloproliferative Neoplasm
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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.
Olivier MANSIER principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Bordeaux at 5 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 4 inclusion and 11 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
History of thrombosis (time frame: At inclusion, up to 1 year after diagnosis). 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 30 Jul 2025.