Analyzing the Clonality Profile in Myeloproliferative Neoplasms and Thrombotic Risks
Official title: Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
Run by University Hospital, Bordeaux · NCT05839717 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | ruxolitinib, chemotherapy |
| Locations | 11 sites (Angers and 10 other locations) |
| Status | Recruiting |
| Started | June 19, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | December 17, 2024 |
| Trial ID | NCT05839717 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients without the JAK2V617F mutation or those currently undergoing cytoreductive treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 5 more locations
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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
- Email: olivier.mansier@chu-bordeaux.fr
- Phone: 05 56 79 56 79
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.