Analyzing the Clonality Profile in Myeloproliferative Neoplasms and Thrombotic Risks

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

This study is trying to see if measuring certain genetic markers in blood cells can help predict the risk of blood clots in people with Myeloproliferative Neoplasms.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Bordeaux (other)
• Drugs / interventions: ruxolitinib, chemotherapy
• Locations: 11 sites (Angers and 10 other locations)
• Trial ID: NCT05839717 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with Myeloproliferative Neoplasms (MPN) to investigate the relationship between the JAK2V617F allele burden in various cell types and the risk of thrombotic complications. It aims to measure the allele burden in platelets, red blood cells, granulocytes, and endothelial cells to identify high-risk clonality profiles. By isolating these cells from 120 patients, the study seeks to establish reliable biomarkers for predicting thrombotic risk in MPN patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have been diagnosed with Polycythemia Vera or Essential Thrombocythemia and carry the JAK2V617F mutation.

Not a fit: Patients without the JAK2V617F mutation or those currently undergoing cytoreductive treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with Myeloproliferative Neoplasms.

How similar studies have performed: While some studies have explored the JAK2V617F mutation's association with thrombotic risk, this approach of analyzing multiple cell types for clonality profiles is relatively novel.

Eligibility 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

Where this trial is running

Angers and 10 other locations

• CHU d'Angers, Service Maladies du Sang — Angers, France (RECRUITING)
• CH de Bayonne, Service Hématologie Clinique — Bayonne, France (RECRUITING)
• CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses — Bordeaux, France (RECRUITING)
• Institut Bergonié, Service Hématologie Clinique — Bordeaux, France (RECRUITING)
• CHU de Brest, Service Hématologie Clinique — Brest, France (RECRUITING)
• CH de Dax, Service Hématologie Clinique — Dax, France (RECRUITING)
• CH de Libourne, Service Hématologie Clinique — Libourne, France (RECRUITING)
• CH de Mont de Marsan, Service Oncologie — Mont-de-Marsan, France (RECRUITING)
• CHU de Bordeaux, Service Hématologie Biologie — Pessac, France (RECRUITING)
• CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire — Pessac, France (RECRUITING)
• CHU de Bordeaux, Service Médecine Interne — Pessac, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Olivier MANSIER

Conditions: Myeloproliferative Neoplasm, Myeloproliferative Neoplasms, Thrombosis, Clonality, JAK2V617F