Determination of the Clonality Profile in Myeloproliferative Neoplasms and Association With the Thrombotic Complications (CLOJAK)

NCT05839717 | Recruiting

• 1 other identifier: CHUBX 2022/16
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 11

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.

Conditions

Myeloproliferative Neoplasm

Keywords

Myeloproliferative Neoplasms; Thrombosis; Clonality; JAK2V617F

Outcome Measures

Primary Outcomes (1)

• History of thrombosis at MPN diagnosis

  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

  At inclusion

Secondary Outcomes (8)

• The JAK2V617F allele burden measured in red blood cells

  At inclusion

• The JAK2V617F allele burden measured in platelets

  At inclusion

• The JAK2V617F allele burden measured in granulocytes

  At inclusion

• The presence of the JAK2V617F mutation in endothelial cells

  At inclusion

• The clonality profile

  At inclusion

Study Arms (1)

PV and ET patients

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)

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

A specific blood sampling will be performed in addition to the classical evaluations that are performed in routine practice

PV and ET patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Myeloproliferative Neoplasms (MPN) carrying a JAK2V617F mutation

You may qualify if:

• Adult patient (age ≥ 18 years)
• Patient carrying a JAK2V617F mutation
• Subject registered with a social security scheme
• Written informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (11)

CHU d'Angers, Service Maladies du Sang

Angers, 49933, France

RECRUITING

CH de Bayonne, Service Hématologie Clinique

Bayonne, 64100, France

RECRUITING

CHU de Bordeaux, Service Médecine Interne et Maladies Infectieuses

Bordeaux, 33000, France

RECRUITING

Institut Bergonié, Service Hématologie Clinique

Bordeaux, 33000, France

RECRUITING

CHU de Brest, Service Hématologie Clinique

Brest, 29609, France

RECRUITING

CH de Dax, Service Hématologie Clinique

Dax, 40100, France

RECRUITING

CH de Libourne, Service Hématologie Clinique

Libourne, 33500, France

RECRUITING

CH de Mont de Marsan, Service Oncologie

Mont-de-Marsan, 40000, France

RECRUITING

CHU de Bordeaux, Service Hématologie Biologie

Pessac, 33604, France

RECRUITING

CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire

Pessac, 33604, France

RECRUITING

CHU de Bordeaux, Service Médecine Interne

Pessac, 33604, France

NOT YET RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Olivier MANSIER

CONTACT

05 56 79 56 79; olivier.mansier@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: June 19, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (11)