NCT05839717 Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
| NCT ID | NCT05839717 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Myeloproliferative Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-06-19 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-06-19 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05839717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloproliferative Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05839717 currently recruiting?
Yes, NCT05839717 is actively recruiting participants. Contact the research team at olivier.mansier@chu-bordeaux.fr for enrollment information.
Where is the NCT05839717 trial being conducted?
This trial is being conducted at Angers, France, Bayonne, France, Bordeaux, France, Bordeaux, France and 7 additional locations.
Who is sponsoring the NCT05839717 clinical trial?
NCT05839717 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 120 participants.