Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
NCT ID: NCT05839717
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
120 participants
OBSERVATIONAL
2023-06-19
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
SYTHROM Cohort, Myeloproliferative Neoplasia With Normal CBC and Thrombotic Complications
NCT04539678
Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)
NCT05419648
PREVALENCE STUDY OF PNH CLONES IN PATIENTS WITH NEOPLASIES
NCT06159816
Functional Characterization of Thrombopoietin/cMPL Receptor Mutations in Myeloproliferative Neoplasia
NCT06246006
MASCOT Registry of Patients With Myeloproliferative Neoplasms Associated Splanchnic Vein Thrombosis
NCT04994158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Blood sampling
A specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sampling
A specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Bordeaux
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX 2022/16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.