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Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes

Study Purpose

Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06361641
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Angers
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Agathe GOUBAND, PharmD
Principal Investigator Affiliation University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloproliferative Neoplasm, Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Phemop Cohort

Interventions

Diagnostic Test: - Monocytes signatures in myeloproliferative neoplasms at diagnosis

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.

Contact a Trial Team

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International Sites

GOUBAND Agathe, Angers, Maine Et Loire, France

Status

Recruiting

Address

GOUBAND Agathe

Angers, Maine Et Loire, 49933

Site Contact

Agathe GOUBAND, PharmD

[email protected]

02 41 35 55 96 #33

BESCOND Charles, Cholet, Maine Et Loire, France

Status

Not yet recruiting

Address

BESCOND Charles

Cholet, Maine Et Loire, 49325

Site Contact

Charles BESCOND, MD

[email protected]

0241355880

TRUCHAN-GRACZYK Malgorzata, Saumur, Maine Et Loire, France

Status

Not yet recruiting

Address

TRUCHAN-GRACZYK Malgorzata

Saumur, Maine Et Loire, 49400

Site Contact

Malgorzata TRUCHAN-GRACZYK, MD

[email protected]

0241533544 #33