Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms

NCT ID: NCT04177576

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 397 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2022-01-26

Brief Summary

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.

Detailed Description

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.

Conditions

Myeloproliferative Neoplasm

Study Design

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

Study Groups

Patients with myeloproliferative neoplasms (MPN)

Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET)

2 additional tubes of blood

Intervention Type: BIOLOGICAL

2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation

Interventions

2 additional tubes of blood

2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adults (age ≥18 years),
• Patients diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET) according to WHO 2008 criteria,
• Affiliated to the national social security system,
• Signed informed consent form will be required for each included subject after having read the information note,
• Patient agreeing to be included in the FIMBANK register and having signed the corresponding consent

Exclusion Criteria

• Adults (age >18 years), male or female,
• Patients treated with heparin or undergoing cytoreductive treatment,
• Pregnant or lactating woman,
• Person under guardianship, tutorship or other legal protection scheme or incapable of giving consent

• 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

Chloé JAMES

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU Angers

Angers, , France

CH Annecy Genevois

Annecy, , France

CH Avignon

Avignon, , France

CHU Bordeaux, Hématologie Biologique

Bordeaux, , France

CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire

Bordeaux, , France

CHU Bordeaux, Médecine Interne

Bordeaux, , France

Institut Bergonié

Bordeaux, , France

CHRU Brest

Brest, , France

CHU Henri Mondor - APHP

Créteil, , France

CH Dax

Dax, , France

CHU Dijon

Dijon, , France

CHU Limoges

Limoges, , France

Centre Léon Bérard

Lyon, , France

CH Mont de Marsan

Mont-de-Marsan, , France

CHU Nancy

Nancy, , France

Hôpital Européen Georges Pompidou - APHP

Paris, , France

Hôpital Saint-Louis - APHP

Paris, , France

CH Perpignan

Perpignan, , France

CHU Poitiers

Poitiers, , France

CH Rochefort

Rochefort, , France

CH Roubaix

Roubaix, , France

IUCT-Oncopôle

Toulouse, , France

CH Valenciennes

Valenciennes, , France

Hôpital Paul Brousse

Villejuif, , France

Countries

France

Other Identifiers

CHUBX 2018/50

Identifier Type: -

Identifier Source: org_study_id