Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)

NCT ID: NCT05419648

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2025-07-22

Brief Summary

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.

Detailed Description

Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by an increased risk of thrombosis, in particular in Polycythemia Vera (PV) and Essential Thrombocythemia (ET). Predicting the risk of thrombosis in PV and ET patients helps at determining their care (use of antiaggregant and cytoreductive therapies), but relies only on limited clinical and biological criteria (age over 60 years, history of thrombosis, presence of the JAK2V617F mutation, presence of cardiovascular risk factors). Monocytes sub-populations could represent a new biomarker of thrombotic risk in PV and ET patients. Indeed, it has been shown that monocytes are activated and exhibit pro-thrombotic properties in MPN patients, especially those with a history of thrombosis. Some studies have suggested the CD16+ monocytes (intermediate and non-classical monocytes) are associated with an increased risk of arterial thrombosis. Because these monocytes are observed in inflammatory contexts, and because MPN are associated with a chronic inflammation, MPN could be associated with an increase of the proportion or the absolute count of CD16+ monocytes that could be involved in thrombotic complications observed in PV and ET patients.

In this project, an association between the proportion of CD16+ monocytes and thrombosis in PV and ET patients will be searched. Monocytes sub-populations will be studied in PV and ET patients at diagnosis as described by Selimoglu-Buet et al.1 The proportion of CD16+ (intermediate + non-classical) monocytes will be compared between patients presenting with a history of thrombosis and those without any history of thrombosis. The association between the absolute count and the proportion of CD16+, intermediate and non-classical monocytes and the occurrence of thrombosis before diagnosis, the MPN phenotype, the driver mutation, the allelic burden, the clinico-biological presentation and the existence of an inflammatory state will also be evaluated. Due to the low frequency and the high latency of thrombosis reoccurrence, patients' samples only at diagnosis (or during the year after diagnosis) will be analyzed and an association with a history of thrombosis will be made.

Conditions

Myeloproliferative Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PV and ET patients

For the main objective, the cohort will be composed of PV and ET patients, some with a history of thrombosis and some without any history of thrombosis. A comparison will also be performed between patients with different MPN (PV or ET) and different driver mutation (JAK2V617F, JAK2 exon 12, CALR, MPL or absence of such mutations)

1 additional tube of blood

Intervention Type: BIOLOGICAL

For all the patients included, a specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice

Interventions

1 additional tube of blood

For all the patients included, a specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier MANSIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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, , France

Countries

France

Other Identifiers

CHUBX 2021/29

Identifier Type: -

Identifier Source: org_study_id