Trial Title:
Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
NCT ID:
NCT05839717
Condition:
Myeloproliferative Neoplasm
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Conditions: Keywords:
Myeloproliferative Neoplasms
Thrombosis
Clonality
JAK2V617F
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Blood sampling
Description:
A specific blood sampling will be performed in addition to the classical evaluations that
are performed in routine practice
Arm group label:
PV and ET patients
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.
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.
Criteria for eligibility:
Study pop:
Patient with Myeloproliferative Neoplasms (MPN) carrying a JAK2V617F mutation
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU d'Angers, Service Maladies du Sang
Address:
City:
Angers
Zip:
49933
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
François BOYER
Email:
Frboyer-perrard@chu-angers.fr
Facility:
Name:
CH de Bayonne, Service Hématologie Clinique
Address:
City:
Bayonne
Zip:
64100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Baptiste ROBIN
Email:
jbrobin@ch-cotebasque.fr
Facility:
Name:
CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pierre DUFFAU
Email:
pierre.duffau@chu-bordeaux.fr
Facility:
Name:
Institut Bergonié, Service Hématologie Clinique
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Etienne GABRIEL
Email:
G.Etienne@bordeaux.unicancer.fr
Facility:
Name:
CHU de Brest, Service Hématologie Clinique
Address:
City:
Brest
Zip:
29609
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Eric LIPPERT
Email:
eric.lippert@chu-brest.fr
Facility:
Name:
CH de Dax, Service Hématologie Clinique
Address:
City:
Dax
Zip:
40100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Clémentine SALVADO
Email:
salvadoc@ch-dax.fr
Facility:
Name:
CH de Libourne, Service Hématologie Clinique
Address:
City:
Libourne
Zip:
33500
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Diane LARA
Email:
Diane.Lara@ch-libourne.fr
Facility:
Name:
CH de Mont de Marsan, Service Oncologie
Address:
City:
Mont-de-Marsan
Zip:
40000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Samia MADENE
Email:
samia.madene@ch-mdm.fr
Facility:
Name:
CHU de Bordeaux, Service Hématologie Biologie
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Contact:
Last name:
Chloé JAMES
Email:
chloe.james@chu-bordeaux.fr
Facility:
Name:
CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Clémence MEDIAVILLA
Email:
clemence.mediavilla@chu-bordeaux.fr
Facility:
Name:
CHU de Bordeaux, Service Médecine Interne
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-François VIALLARD
Email:
jean-francois.viallard@chu-bordeaux.fr
Start date:
June 19, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University Hospital, Bordeaux
Agency class:
Other
Source:
University Hospital, Bordeaux
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05839717
