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Completed

NCT Number: NCT04177576

Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 additional tubes of blood

Biological

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

Primary outcomes

  1. Correlation between NET biomarkers and the risk of thrombosis

    Time frame: 1 day

    Correlation between NET biomarkers measurated in plasma samples and the risk of thrombosis evaluated by the prognostic score IPSET thrombosis

Secondary outcomes

  1. Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis

    Time frame: 1 day

  2. Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the subtype of MPN disease (ET or PV)

    Time frame: 1 day

  3. Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: MPN-BIOCLOT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2019
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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