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

December 16, 2024 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Myeloproliferative Neoplasms (MPN) are hematological malignancies associated with an increased risk of thrombosis. Although different cell types have been involved in these complications (platelets, red blood cells, leucocytes and endothelial cells), there do not exist any reliable biomarker to predict the thrombotic risk in MPN patients. While some studies suggested that the JAK2V617F allele burden measured in leukocytes was associated with the risk of thrombosis, other studies did not confirm these results. Besides, a recent work demonstrated that in some patients, the JAK2V617F allele burden measured in platelets and red blood cells was higher than the one determined in leukocytes. Moreover, some patients present JAK2V617F mutated endothelial cells, known as pro-thrombotic in in vitro and animal models. The CLOJAK project will search for an association between the thrombotic risk in MPN and the proportion of cells carrying the JAK2V617F mutation in erythroid cells and platelets or its presence in endothelial cells. The objective is to determine a clonality profile (i.e. the profile of repartition of the JAK2V617F allele burden in the different hematopoietic and endothelial lineages) associated with the occurrence of thrombosis in MPN patients.

One hundred and twenty PV and ET patients will be studied at diagnosis. Their platelets, red blood cells, granulocytes and endothelial cells will be isolated. The JAK2V617F allele burden will be measured in these cells thanks to a digital PCR technic. An association between the clonality profile and the existence of a thrombosis at diagnosis, the MPN phenotype (PV or ET), the IPSET-thrombosis score and the type of thrombosis (venous, arterial, splanchnic) will be searched.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Angers, France, 49933
      • Bayonne, France, 64100
      • Bordeaux, France, 33000
      • Bordeaux, France, 33000
      • Brest, France, 29609
      • Dax, France, 40100
        • Recruiting
        • CH de Dax, Service Hématologie Clinique
        • Contact:
      • Libourne, France, 33500
      • Mont-de-Marsan, France, 40000
      • Pessac, France, 33604
      • Pessac, France, 33604
      • Pessac, France, 33604

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with Myeloproliferative Neoplasms (MPN) carrying a JAK2V617F mutation

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

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
PV and ET patients
The cohort will be composed of PV and ET patients, some with a history of thrombosis and some without any history of thrombosis. A comparison will also be performed between patients with different MPN (PV or ET) and the type of thrombosis (venous, arterial, splanchnic)
Procedure: Blood sampling
A specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
History of thrombosis at MPN diagnosis
Time Frame: At inclusion
History of thrombosis at MPN diagnosis defined as the occurrence of a venous (deep vein thrombosis, pulmonary embolism) or arterial thrombosis (ischemic stroke or myocardial infarction) or a thrombosis in the splanchnic area
At inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The JAK2V617F allele burden measured in red blood cells
Time Frame: At inclusion
At inclusion
The JAK2V617F allele burden measured in platelets
Time Frame: At inclusion
At inclusion
The JAK2V617F allele burden measured in granulocytes
Time Frame: At inclusion
At inclusion
The presence of the JAK2V617F mutation in endothelial cells
Time Frame: At inclusion
At inclusion
The clonality profile
Time Frame: At inclusion
The clonality profile defined based on the association of cell lineages in which a JAK2V617F allele burden over 25% is measured together with the detection (or not) of the JAK2V617F mutation in endothelial cells
At inclusion
The type of MPN according to the 2016 WHO classification of hematological malignancies
Time Frame: At inclusion
At inclusion
The IPSET-Thrombosis score
Time Frame: At inclusion
At inclusion
The type of thrombosis
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

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

Sponsor

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)

June 19, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/16

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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