Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Monocytes signatures in myeloproliferative neoplasms at diagnosis

    Diagnostic test

    The 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

70 Participants
are divided into 1 treatment group
Group A: Phemop CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 0

Secondary outcomes

1

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

Time frame
24 months
2

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)

Time frame
24 months
3

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

Time frame
12, 24 months
4

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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.