Clinical trial · Observational
Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PV and ET patients
- description
- 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)
- interventionNames
- Procedure: Blood sampling
Primary outcomes (1)
- measure
- History of thrombosis at MPN diagnosis
- timeFrame
- At inclusion
- description
- 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
Secondary outcomes (8)
- measure
- The JAK2V617F allele burden measured in red blood cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available