NCT05839717Recruiting
Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)
Source: ClinicalTrials.gov · Last updated 17 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 20 Apr 2023
- Start date
- 19 Jun 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT05839717
What you commit to
- Study type: Observational
- Planned participants: 120
- From 19 Jun 2023 to the primary completion date, Dec 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with cytoreductive treatment (hydroxyurea, anagrelide, interferon, ruxolitinib or other chemotherapy) at the time of blood sampling
- Exclusion period after another clinical study or participation to another clinical study in the 30 days before inclusion
Other
- ET or PV Patient not carrying a JAK2V617F mutation
- Person under judicial safeguards, trustee or curatorship
- Person unable to give her consent
- Non-cooperative person
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d'Angers, Service Maladies du Sang Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| CH de Bayonne, Service Hématologie Clinique Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Institut Bergonié, Service Hématologie Clinique Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Brest, Service Hématologie Clinique Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| CH de Dax, Service Hématologie Clinique Coordinator of this site? Confirm its status | Dax | France | Recruiting |
| CH de Libourne, Service Hématologie Clinique Coordinator of this site? Confirm its status | Libourne | France | Recruiting |
| CH de Mont de Marsan, Service Oncologie Coordinator of this site? Confirm its status | Mont-de-Marsan | France | Recruiting |
| CHU de Bordeaux, Service Médecine Interne Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| CHU de Bordeaux, Service Hématologie Biologie Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.