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

NCT05419648 | Completed

• 1 other identifier: CHUBX 2021/29
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 5

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.

Conditions

Myeloproliferative Neoplasm

Keywords

Myeloproliferative Neoplasms; Thrombosis; Monocytes sub-populations; Flow cytometry

Outcome Measures

Primary Outcomes (1)

• History of thrombosis

  Patients wil be classified as having a history of thrombosis if they had a deep vein thrombosis, pulmonary embolism, splanchnic thombosis or any other significant thrombosis. Tinnitus, vertigo, headaches, erythromelalgia as well as superficial vein thrombosis will not be considered as thrombotic events

  At inclusion, up to 1 year after diagnosis

Secondary Outcomes (9)

• Proportion of CD16+ monocytes in PV and ET patients

  At inclusion, up to 1 year after diagnosis

• Proportion of monocytes sub-populations

  At inclusion, up to 1 year after diagnosis

• Count of monocytes sub-populations

  At inclusion, up to 1 year after diagnosis

• Type of MPN

  At inclusion, up to 1 year after diagnosis

• Driver mutation of MPN

  At inclusion, up to 1 year after diagnosis

Study Arms (1)

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)

Biological: 1 additional tube of blood

Interventions

1 additional tube of blood 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

PV and ET patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Polycythemia Vera (PV) or Essential Thrombocythemia (ET), the 2 Myeloproliferative Neoplasms (MPN) most associated with a risk of thrombosis

You may qualify if:

• Adults patients (age ≥ 18 years)
• Subject registered with a social security scheme
• Written informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CHU de Bordeaux, Hématologie clinique et thérapie cellulaire

Bordeaux, France

Location

CHU de Bordeaux, Laboratoire Hématologie

Bordeaux, France

Location

CHU de Bordeaux, Médecine interne et immunologie clinique

Bordeaux, France

Location

CHU de Bordeaux, Médecine Interne et maladies infectieuses

Bordeaux, France

Location

Institut Begonié, Hématologie clinique

Bordeaux, France

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombosis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier MANSIER

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 15, 2022
• Study Start: October 5, 2022
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)