Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms (MPN-BIOCLOT)

October 5, 2022 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

397

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Angers, France
        • CHU Angers
      • Annecy, France
        • Ch Annecy Genevois
      • Avignon, France
        • CH Avignon
      • Bordeaux, France
        • Institut Bergonié
      • Bordeaux, France
        • CHU Bordeaux, Hématologie Biologique
      • Bordeaux, France
        • CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire
      • Bordeaux, France
        • CHU Bordeaux, Médecine Interne
      • Brest, France
        • CHRU Brest
      • Créteil, France
        • CHU Henri Mondor - APHP
      • Dax, France
        • CH Dax
      • Dijon, France
        • CHU Dijon
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Centre Leon Berard
      • Mont-de-Marsan, France
        • CH Mont de Marsan
      • Nancy, France
        • Chu Nancy
      • Paris, France
        • Hôpital européen Georges Pompidou - APHP
      • Paris, France
        • Hopital Saint-Louis - APHP
      • Perpignan, France
        • CH Perpignan
      • Poitiers, France
        • CHU Poitiers
      • Rochefort, France
        • CH Rochefort
      • Roubaix, France
        • CH Roubaix
      • Toulouse, France
        • IUCT-Oncopole
      • Valenciennes, France
        • CH Valenciennes
      • Villejuif, France
        • Hôpital Paul Brousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with myeloproliferative neoplasms (MPN), diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with myeloproliferative neoplasms (MPN)
Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET)
2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis
Time Frame: 1 day
1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the subtype of MPN disease (ET or PV)
Time Frame: 1 day
1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chloé JAMES, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 24, 2020

Primary Completion (ACTUAL)

January 26, 2022

Study Completion (ACTUAL)

January 26, 2022

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (ACTUAL)

November 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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