Prognostic Value of NETosis Markers for Thrombosis During Myeloproliferative Neoplasms (AVATARE)

NCT07119970 | Recruiting

• 1 other identifier: CHUBX 2023/91
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 15

Brief Summary

Myeloproliferative neoplasms are hematologic diseases characterized by an increased proliferation of peripheral blood cells. The main risk of MPN is the occurrence of thrombosis. Thrombosis risk is mainly evaluated using two criteria: age and prior thrombosis. A better prediction of thrombosis risk is needed to improve prevention and treatment of MPN-associated thrombosis. The objective of the study is to evaluate the predictive value of neutrophil extracellular traps markers in thrombosis during MPN.

Conditions

Myeloproliferative Neoplasm; Myeloproliferative Disorders

Keywords

Myeloproliferative neoplasms; Thrombosis; Neutrophil extracellular traps; Neutrophils

Outcome Measures

Primary Outcomes (1)

• Serum calprotectin concentration

  This concentration will be compared between MPN patients who develop thrombotic events during the follow-up and those who do not. The serum concentration will be measured using automated immunoturbidimetric test and the results will be analyzed to assess its association with future thrombotic events in patients with myeloproliferative neoplasms.

  At T0 (inclusion)

Secondary Outcomes (4)

• Serum calprotectin concentration

  At T1 (12 months post-inclusion)

• Serum concentration of citrullinated histone H3 (H3Cit)

  At T1 (12 months post-inclusion)

• Plasma citrullinated histone 3 concentration

  At T0 (inclusion)

• Plasma citrullinated histone 3 concentration

  At T1 (12 months post-inclusion)

Study Arms (2)

Direct oral anticoagulants (DOACs)

EXPERIMENTAL

Biological: Additional blood sampling

Aspirin

ACTIVE COMPARATOR

Biological: Additional blood sampling

Interventions

Additional blood sampling BIOLOGICAL

At inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis

Aspirin; Direct oral anticoagulants (DOACs)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Polycythemia Vera (PV), Essential Thrombocythemia (ET), or pre-myelofibrosis (pre-MF)
• JAK2V617F mutation with an allelic burden greater than 1%
• High risk of thrombosis (age over 60 years or prior thrombotic event)
• Diagnosis of MPN within the last 12 months
• Enrollment in the AVAJAK clinical trial and the FIMBANK biobank
• Affiliation with social security
• Signed informed consent

You may not qualify if:

• Severe hepatic or renal insufficiency (Creatinine clearance \<30ml/min)
• Patients under legal protection (guardianship or curatorship)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (15)

CHU d'Angers, Service des maladies du Sang

Angers, 49933, France

NOT YET RECRUITING

CH de la Côte Basque, Service Hématologie

Bayonne, 64100, France

NOT YET RECRUITING

CHU de Bordeaux, Service Hématologie Biologique

Bordeaux, 33600, France

NOT YET RECRUITING

CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire

Bordeaux, 33600, France

NOT YET RECRUITING

CHU de Brest, Service Hématologie et Hémostase Clinique

Brest, 29609, France

NOT YET RECRUITING

APHP-Hôpital Mondor, Service Hématologie Clinique et Thérapie Cellulaire

Créteil, 94010, France

NOT YET RECRUITING

CHD de Vendée, Service Onco-hématologie

La Roche-sur-Yon, 85925, France

NOT YET RECRUITING

APHP-Hôpital Bicêtre, Service Hématologie Clinique Ambulatoire

Le Kremlin-Bicêtre, 94270, France

NOT YET RECRUITING

CH de Libourne, Service Hématologie

Libourne, 33505, France

RECRUITING

CHU de Limoges, Service Hématologie Clinique et de Thérapie Cellulaire

Limoges, 87042, France

NOT YET RECRUITING

CH des Pays de Morlaix, Service Onco-Hématologie

Morlaix, 29672, France

NOT YET RECRUITING

CHU de Nantes, Service Hématologie Clinique

Nantes, 44093, France

NOT YET RECRUITING

Hôpital Privé du Confluent, Service Hématologie

Nantes, 44202, France

NOT YET RECRUITING

APHO-Hôpital Saint-Louis, Centre d'Investigations Cliniques

Paris, 75010, France

NOT YET RECRUITING

CH de Roubaix, Service Hématologie

Roubaix, 59100, France

NOT YET RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexandre GUY

  alexandre.guy@chu-bordeaux.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre GUY

CONTACT

0557656478; alexandre.guy@chu-bordeaux.fr

Chloé JAMES

CONTACT

0557891979; chloe.james@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: August 13, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)