Investigating Monocyte Sub-populations in Thrombosis for Myeloproliferative Neoplasms
Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
This study is trying to see if certain types of blood cells called monocytes can help predict the risk of blood clots in people with myeloproliferative neoplasms like Polycythemia Vera and Essential Thrombocythemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | ruxolitinib |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT05419648 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between monocyte sub-populations and the risk of thrombosis in patients diagnosed with myeloproliferative neoplasms (MPN), specifically Polycythemia Vera (PV) and Essential Thrombocythemia (ET). By analyzing blood samples from patients at diagnosis or within a year of diagnosis, the study will focus on the proportion of CD16+ monocytes, which may serve as a new biomarker for thrombotic risk. The findings could enhance the understanding of thrombotic complications in MPN and potentially guide treatment decisions. The study will utilize flow cytometry to assess monocyte characteristics in the patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are newly diagnosed with Polycythemia Vera or Essential Thrombocythemia.
Not a fit: Patients currently undergoing cytoreductive treatment or those with chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for thrombosis in MPN patients.
How similar studies have performed: While the specific approach of studying monocyte sub-populations in MPN is novel, previous studies have indicated a link between monocyte activation and thrombosis in other contexts.
Eligibility criteria
Show full 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
Where this trial is running
Bordeaux and 4 other locations
- CHU de Bordeaux, Hématologie clinique et thérapie cellulaire — Bordeaux, France (Recruiting)
- CHU de Bordeaux, Laboratoire Hématologie — Bordeaux, France (Recruiting)
- CHU de Bordeaux, Médecine interne et immunologie clinique — Bordeaux, France (Recruiting)
- CHU de Bordeaux, Médecine Interne et maladies infectieuses — Bordeaux, France (Recruiting)
- Institut Begonié, Hématologie clinique — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Olivier MANSIER — University Hospital, Bordeaux
- Study coordinator: Olivier MANSIER
- Email: olivier.mansier@chu-bordeaux.fr
- Phone: 05 56 79 56 79 (poste 74601)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.