Myeloproliferative NeoplasmCLOJAKNCT05839717
Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Bordeaux at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 11 sitesFrance
- Study dates
- 19 Jun 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Myeloproliferative Neoplasms (MPN) carrying a JAK2V617F mutation
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CHU d'Angers, Service Maladies du Sang
Angers, 49933
François BOYER, Frboyer-perrard@chu-angers.fr
- Recruiting
CH de Bayonne, Service Hématologie Clinique
Bayonne, 64100
Harmony LEROY, hleroy@ch-cotebasque.fr
- Recruiting
CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses
Bordeaux, 33000
Pierre DUFFAU, pierre.duffau@chu-bordeaux.fr
- Recruiting
Institut Bergonié, Service Hématologie Clinique
Bordeaux, 33000
Etienne GABRIEL, G.Etienne@bordeaux.unicancer.fr
- Recruiting
CHU de Brest, Service Hématologie Clinique
Brest, 29609
Eric LIPPERT, eric.lippert@chu-brest.fr
- Recruiting
CH de Dax, Service Hématologie Clinique
Dax, 40100
Clémentine SALVADO, salvadoc@ch-dax.fr
- Recruiting
CH de Libourne, Service Hématologie Clinique
Libourne, 33500
Diane LARA, Diane.Lara@ch-libourne.fr
- Recruiting
CH de Mont de Marsan, Service Oncologie
Mont-de-Marsan, 40000
Samia MADENE, samia.madene@ch-mdm.fr
- Recruiting
CHU de Bordeaux, Service Hématologie Biologie
Pessac, 33604
Chloé JAMES, chloe.james@chu-bordeaux.fr
- Recruiting
CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire
Pessac, 33604
Clémence MEDIAVILLA, clemence.mediavilla@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux, Service Médecine Interne
Pessac, 33604
Jean-François VIALLARD, jean-francois.viallard@chu-bordeaux.fr
About this study
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.
Read the 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.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Blood sampling
- Keywords
- Myeloproliferative Neoplasms, Thrombosis, Clonality, JAK2V617F
- Medical subject headings
- Myeloproliferative Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
A specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
History of thrombosis at MPN diagnosis
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
Measured: At inclusion
Secondary outcomes (8)
The JAK2V617F allele burden measured in red blood cells
Measured: At inclusion
The JAK2V617F allele burden measured in platelets
Measured: At inclusion
The JAK2V617F allele burden measured in granulocytes
Measured: At inclusion
The presence of the JAK2V617F mutation in endothelial cells
Measured: At inclusion
The clonality profile
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
Measured: At inclusion
The type of MPN according to the 2016 WHO classification of hematological malignancies
Measured: At inclusion
The IPSET-Thrombosis score
Measured: At inclusion
The type of thrombosis
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 Jun 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839717
- Sponsor's protocol ID
- CHUBX 2022/16
- Acronym
- CLOJAK
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
- ClinicalTrials.gov ID
- NCT05839717
- Acronym / sponsor ID
- CLOJAK / CHUBX 2022/16
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- Myeloproliferative Neoplasms, Thrombosis, Clonality, JAK2V617F
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PV and ET patients | – | Procedure: Blood samplingThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Myeloproliferative Neoplasms (MPN) carrying a JAK2V617F mutation
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingA specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice | Procedure or surgery | PV and ET patients |
Primary outcome
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
8 secondary outcomes
The JAK2V617F allele burden measured in red blood cells
Time frame: At inclusion
The JAK2V617F allele burden measured in platelets
Time frame: At inclusion
The JAK2V617F allele burden measured in granulocytes
Time frame: At inclusion
The presence of the JAK2V617F mutation in endothelial cells
Time frame: At inclusion
The clonality profile
Time frame: At inclusion
The type of MPN according to the 2016 WHO classification of hematological malignancies
Time frame: At inclusion
The IPSET-Thrombosis score
Time frame: At inclusion
The type of thrombosis
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Bordeaux at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier MANSIER (05 56 79 56 79 ext. 49113, olivier.mansier@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
History of thrombosis at MPN diagnosis (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.