RecruitingNCT05839717

Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)


Sponsor

University Hospital, Bordeaux

Enrollment

120 participants

Start Date

Jun 19, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Myeloproliferative Neoplasms (MPN) are associated with an increased risk of thrombosis. Platelets, red blood cells (RBC), leukocytes and endothelial cells are involved in these complications. An association with the JAK2V617F allele burden assessed in leukocytes has also been suggested. In some patients the allele burden measured in platelets and red blood cells is higher than the one determined in leukocytes. Our project aims at associating the risk of thrombosis with the allele burden determined in the cell populations (platelets, red blood cells, granulocytes and endothelial cells) and identifying high-risk clonality profiles.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Adult patient (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), before introduction of a cytoreductive treatment
  • Patient carrying a JAK2V617F mutation
  • Subject registered with a social security scheme
  • Written informed consent obtained
  • Acceptance of inclusion in the FIMBANK registry (specific consent form needed)

Exclusion Criteria6

  • ET or PV Patient not carrying a JAK2V617F mutation
  • Patient with cytoreductive treatment (hydroxyurea, anagrelide, interferon, ruxolitinib or other chemotherapy) at the time of blood sampling
  • Person 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

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Interventions

PROCEDUREBlood sampling

A specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice


Locations(11)

CHU d'Angers, Service Maladies du Sang

Angers, France

CH de Bayonne, Service Hématologie Clinique

Bayonne, France

CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses

Bordeaux, France

Institut Bergonié, Service Hématologie Clinique

Bordeaux, France

CHU de Brest, Service Hématologie Clinique

Brest, France

CH de Dax, Service Hématologie Clinique

Dax, France

CH de Libourne, Service Hématologie Clinique

Libourne, France

CH de Mont de Marsan, Service Oncologie

Mont-de-Marsan, France

CHU de Bordeaux, Service Hématologie Biologie

Pessac, France

CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire

Pessac, France

CHU de Bordeaux, Service Médecine Interne

Pessac, France

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NCT05839717


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