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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
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

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CHU d'Angers, Service Maladies du Sang
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AngersFranceRecruiting
CH de Bayonne, Service Hématologie Clinique
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BayonneFranceRecruiting
CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses
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BordeauxFranceRecruiting
Institut Bergonié, Service Hématologie Clinique
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BordeauxFranceRecruiting
CHU de Brest, Service Hématologie Clinique
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BrestFranceRecruiting
CH de Dax, Service Hématologie Clinique
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DaxFranceRecruiting
CH de Libourne, Service Hématologie Clinique
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LibourneFranceRecruiting
CH de Mont de Marsan, Service Oncologie
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Mont-de-MarsanFranceRecruiting
CHU de Bordeaux, Service Médecine Interne
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PessacFranceNot yet recruiting
CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire
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PessacFranceRecruiting
CHU de Bordeaux, Service Hématologie Biologie
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PessacFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.