Myeloproliferative Neoplasm Clinical Trial
— MonSThrOfficial title:
Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
NCT number | NCT05419648 |
Other study ID # | CHUBX 2021/29 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2022 |
Est. completion date | October 2024 |
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux, Hématologie clinique et thérapie cellulaire | Bordeaux | |
France | CHU de Bordeaux, Laboratoire Hématologie | Bordeaux | |
France | CHU de Bordeaux, Médecine interne et immunologie clinique | Bordeaux | |
France | CHU de Bordeaux, Médecine Interne et maladies infectieuses | Bordeaux | |
France | Institut Begonié, Hématologie clinique | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At inclusion, up to 1 year after diagnosis | |
Secondary | 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 | At inclusion, up to 1 year after diagnosis | |
Secondary | 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 | At inclusion, up to 1 year after diagnosis | |
Secondary | 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 | At inclusion, up to 1 year after diagnosis | |
Secondary | 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. |
At inclusion, up to 1 year after diagnosis | |
Secondary | 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 | At inclusion, up to 1 year after diagnosis | |
Secondary | Hemoglobin level | A correlation between the hemoglobin level (g/dL) and monocytes sub-populations proportion will be searched | At inclusion, up to 1 year after diagnosis | |
Secondary | Platelets level | A correlation between the platelets level (G/L) and monocytes sub-populations proportion will be searched | At inclusion, up to 1 year after diagnosis | |
Secondary | Leukocytes level | A correlation between the leukocytes level (G/L) and monocytes sub-populations proportion will be searched | At inclusion, up to 1 year after diagnosis | |
Secondary | 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) | At inclusion, up to 1 year after diagnosis |
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