Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.
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 |
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. |
NCT04177576 |
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. |
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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. |
Chloé JAMES |
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 |
Myeloproliferative neoplasms (MPN) are acquired clonal hematopoietic stem cell disorders, characterized by an increase in one or more myeloid lineages. The Philadelphia chromosome negative (Ph-) MPN include polycythemia vera (PV) with an excess of red blood cells, essential thrombocythemia (ET) with an increase in platelets and primary myelofibrosis (PMF). Arterial and venous thromboses are the main causes of morbidity and mortality in MPN with reported incidences ranging from 12-39% in PV and 11-25% in ET. The pathogenesis of thrombosis in MPN patients is complex and still largely elusive. The overproduction of neutrophils could be an important risk factor in the thrombus formation. Indeed neutrophils are known to promote thrombosis when they release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". Increased NETosis has been reported in a mouse model of MPN. The main objective of this study is to investigate whether NET biomarkers are associated with increased thrombotic risk in patients with ET. Indeed, an international thrombotic prognostic score has been published in ET, ie the IPSET Thrombosis score (history of thrombosis, age, presence of JAK2V617F, cardiovascular risk factors). Plasma from MPN patients will be collected, at the time of diagnosis, and measure markers of neutrophil activation, including NET biomarkers. The IPSET Thrombosis score will be evaluated in patients with ET and the correlation between the IPSET Thrombosis score and these biomarkers will be measured. No follow-up is required for this study.
: Patients with myeloproliferative neoplasms (MPN)
Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET)
Biological: - 2 additional tubes of blood
2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation
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.
Status
Recruiting
Address
CHU Angers
Angers, ,
Status
Recruiting
Address
CH Annecy Genevois
Annecy, ,
Status
Recruiting
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CH Avignon
Avignon, ,
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Recruiting
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CHU Bordeaux, Hématologie Biologique
Bordeaux, ,
Status
Recruiting
Address
CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire
Bordeaux, ,
Status
Not yet recruiting
Address
CHU Bordeaux, Médecine Interne
Bordeaux, ,
Status
Recruiting
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Institut Bergonié
Bordeaux, ,
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Not yet recruiting
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CHRU Brest
Brest, ,
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Recruiting
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CHU Henri Mondor - APHP
Créteil, ,
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Not yet recruiting
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CH Dax
Dax, ,
Status
Not yet recruiting
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CHU Dijon
Dijon, ,
Status
Recruiting
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CHU Limoges
Limoges, ,
Status
Recruiting
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Centre Léon Bérard
Lyon, ,
Status
Recruiting
Address
CH Mont de Marsan
Mont-de-Marsan, ,
Status
Not yet recruiting
Address
CHU Nancy
Nancy, ,
Status
Recruiting
Address
Hôpital Européen Georges Pompidou - APHP
Paris, ,
Status
Recruiting
Address
Hôpital Saint-Louis - APHP
Paris, ,
Status
Not yet recruiting
Address
Hôpital Tenon - APHP
Paris, ,
Status
Recruiting
Address
CH Perpignan
Perpignan, ,
Status
Recruiting
Address
CHU Poitiers
Poitiers, ,
Status
Recruiting
Address
CH Rochefort
Rochefort, ,
Status
Not yet recruiting
Address
CH Roubaix
Roubaix, ,
Status
Recruiting
Address
IUCT-Oncopôle
Toulouse, ,
Status
Recruiting
Address
CH Valenciennes
Valenciennes, ,
Status
Recruiting
Address
Hôpital Paul Brousse
Villejuif, ,