About this trial
Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of PV, ET, pre-myelofibrosis or primary myelofibrosis according to WHO 2022 criteria (including BOM for ET, premyelofibrosis and primary myelofibrosis)
Patient who has not received treatment specific to hemopathy at the time of sampling
Obtaining the signature of consent to participate in the study
Patient having consented to be included in the "Malignant Hemopathy" collection of Angers University Hospital and in FIMBANK database
Disqualifiers
Person not affiliated to a social security scheme or beneficiary of such a scheme
Patient with another hemopathy or another active cancer at the time of diagnosis
Minor patient at diagnosis (< 18 years old)
Patient not capable or without agreement from the guardian or legal representative
Trial design
Single group
Treatments tested in this trial
Monocytes signatures in myeloproliferative neoplasms at diagnosis
Diagnostic testThe monocytes signatures will be perform from a peripheral blood sample. The signature will be derived from (i) surface marker expression, (ii) cytokines profiles, (iii) genes expression.
Treatment groups
Trial outcomes
Primary outcomes
WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis
Assessment of the monocytic signature against the WHO diagnosis (AUC will be determined)
Secondary outcomes
Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene).
The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis
Identify correlation between the monocytic signature and the grade of fibrosis
The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis The monocytic signature will be compared between the different stages of fibrosis (WHO definition for fibrosis grading)
prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6
Evaluate the prognostic value of the monocytic signature for treatment response The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6 : * Complete response: normal blood counts * Partial response: platelets between 400 and 600 G/L * No response: absence of complete or partial response
Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022
Evaluate the prognostic value of the monocyte signature for disease worsening The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Disease worsening criteria according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022): \- Worsening is defined by the presence of at least one of the following criteria: i) leukocytosis \>12 G/L or presence of immature granulocytes \>2% or erythroblasts \>1%; (ii) anemia (hemoglobin \<12 g/dL in a woman or \<13 g/dL in man) not related to treatment toxicity; (iii) thrombocytopenia (platelet count \<150G/L) not related to treatment toxicity; (iv) onset of splenomegaly or progression of pre-existing splenomegaly; (v) thrombocytosis despite cytoreductive therapy
Sponsors and contacts
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