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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

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

Study Purpose

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.

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.

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

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.

NCT05419648
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.

Lead Sponsor

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

University Hospital, Bordeaux
Principal Investigator

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

Olivier MANSIER
Principal Investigator Affiliation University Hospital, Bordeaux
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
Additional Details

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.

Arms & Interventions

Arms

: 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)

Interventions

Biological: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux, Hématologie clinique et thérapie cellulaire

Bordeaux, ,

Site Contact

Clémence MEDIAVILLA

[email protected]

05 56 79 56 79 (poste 74601)

CHU de Bordeaux, Laboratoire Hématologie, Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux, Laboratoire Hématologie

Bordeaux, ,

Site Contact

Olivier MANSIER

[email protected]

05 56 79 56 79 (poste 74601)

Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux, Médecine interne et immunologie clinique

Bordeaux, ,

Site Contact

Pierre DUFFAU

[email protected]

05 56 79 56 79 (poste 74601)

Bordeaux, France

Status

Recruiting

Address

CHU de Bordeaux, Médecine Interne et maladies infectieuses

Bordeaux, ,

Site Contact

Jean-François VIALLARD

[email protected]

05 56 79 56 79 (poste 74601)

Institut Begonié, Hématologie clinique, Bordeaux, France

Status

Recruiting

Address

Institut Begonié, Hématologie clinique

Bordeaux, ,

Site Contact

Etienne GABRIEL

[email protected]

05 56 79 56 79 (poste 74601)

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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