Trial Title:
Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes
NCT ID:
NCT06361641
Condition:
Myeloproliferative Neoplasm
Polycythemia Vera
Essential Thrombocythemia
Primary Myelofibrosis
Conditions: Official terms:
Polycythemia Vera
Primary Myelofibrosis
Myeloproliferative Disorders
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Monocytes signatures in myeloproliferative neoplasms at diagnosis
Description:
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.
Arm group label:
Phemop Cohort
Summary:
Prospective study for functional and phenotypic characterization of monocytes in
philadelphia-negative myeloproliferative neoplasms
Detailed description:
Philadelphia-negative myeloproliferative neoplasms (MPN) are clonal disorders of the
hematopoietic stem cell characterized by an excessive production of mature myeloid cells.
MPNs are characterized by the presence of somatic gain-of-function mutations present in
more than 80% of cases and affecting JAK2, CALR or MPL genes. These mutations lead to a
constitutive activation of the JAK-STAT signaling pathway at the origin of cell
proliferation.
MPN include polycythemia vera (PV), essential thrombocythemia (ET), prefibrotic primary
myelofibrosis (pre-PMF), and primary myelofibrosis (PMF). Despite the classification of
MPNs into distinct subtypes based on clinical and pathological features, the precise
mechanisms underlying the phenotypic diversity within these disorders remain poorly
understood. One aspect that has received limited attention is the role of monocytes and
macrophages, key components of the innate immune system, in MPN pathogenesis.
Monocytes, circulating precursors of tissue-resident macrophages, play essential roles in
inflammation, immune surveillance, and tissue repair. Upon recruitment to tissues,
monocytes differentiate into macrophages with diverse phenotypes and functions influenced
by local microenvironmental cues. Macrophages, in turn, exhibit a spectrum of activation
states ranging from pro-inflammatory (M1) to anti-inflammatory or pro-repair (M2), with
implications for various physiological and pathological processes. Recent studies have
implicated monocytes and macrophages in the pathogenesis of MPNs. Circulating monocytes
in MPN patients display altered functional characteristics, including dysregulated
cytokine production and enhanced fibrotic potential. Additionally, monocytosis, an
elevated monocyte count, has been identified as an adverse prognostic factor in MPNs,
particularly in PMF.
Based on these observations, investigator propose that monocytes and macrophages
contribute to the phenotypic expression of MPNs and that distinct phenotypic and
functional signatures of these cells may be associated with different MPN subtypes. By
leveraging available techniques for genetic and functional analysis, study team aims to
elucidate the role of monocytes and macrophages in MPN pathogenesis and identify
potential biomarkers associated with disease phenotype and prognosis. Through
comprehensive characterization of these immune cell populations, investigator seek to
gain insights into the underlying mechanisms driving the heterogeneity of MPNs and
identify novel therapeutic targets for precision medicine approaches.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GOUBAND Agathe
Address:
City:
Angers
Zip:
49933
Country:
France
Status:
Recruiting
Contact:
Last name:
Agathe GOUBAND, PharmD
Phone:
02 41 35 55 96
Phone ext:
33
Email:
Agathe.Gouband@chu-angers.fr
Contact backup:
Last name:
Damien LUQUE PAZ, PharmD
Phone:
02 41 35 53 53
Phone ext:
33
Email:
Damien.LuquePaz@chu-angers.fr
Investigator:
Last name:
Corentin ORVAIN, MD
Email:
Principal Investigator
Facility:
Name:
BESCOND Charles
Address:
City:
Cholet
Zip:
49325
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Charles BESCOND, MD
Phone:
0241355880
Email:
charles.bescond@ch-cholet.fr
Investigator:
Last name:
Charles Bescond, MD
Email:
Principal Investigator
Facility:
Name:
TRUCHAN-GRACZYK Malgorzata
Address:
City:
Saumur
Zip:
49400
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Malgorzata TRUCHAN-GRACZYK, MD
Phone:
0241533544
Phone ext:
33
Email:
matruchan@ch-saumur.fr
Investigator:
Last name:
Malgorzata TRUCHAN-GRACZYK, MD
Email:
Principal Investigator
Start date:
May 29, 2024
Completion date:
October 19, 2027
Lead sponsor:
Agency:
University Hospital, Angers
Agency class:
Other
Source:
University Hospital, Angers
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361641
