Using NETosis blood markers to predict clot risk in JAK2-positive myeloproliferative neoplasms
Prospective Study for the Evaluation of the Prognostic Value of NETosis Markers to Predict Thrombosis in Myeloproliferative Neoplasms With JAK2V617F Mutation (AVATARE)
This study will try to see if blood markers of NETosis can predict clotting risk in people with JAK2V617F-positive myeloproliferative neoplasms who are at high risk for thrombosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 15 sites (Angers and 14 other locations) |
| Trial ID | NCT07119970 on ClinicalTrials.gov |
What this trial studies
This ancillary study enrolls JAK2V617F-positive patients with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis who are high risk for thrombosis and already taking part in the AVAJAK trial. Participants will have blood drawn at baseline and at 12 months to measure NETosis markers such as calprotectin and citrullinated histone H3 (H3Cit). Marker levels will be correlated with subsequent thrombotic events to test whether NETosis biomarkers improve prediction beyond age and prior thrombosis. The goal is to determine whether these measurements can guide safer, more personalized thrombosis prevention strategies.
Who should consider this trial
Good fit: Ideal candidates are adults with a recent diagnosis (within 12 months) of PV, ET, or pre-MF who are JAK2V617F-positive with allelic burden >1%, meet high-risk criteria (age >60 or prior thrombosis), are enrolled in the AVAJAK trial and the FIMBANK biobank, and can give informed consent.
Not a fit: Patients without a JAK2V617F mutation, those at low thrombotic risk, those on heparin at inclusion, or patients with severe renal or hepatic failure are unlikely to benefit from this biomarker-based prognostic approach.
Why it matters
Potential benefit: If successful, the approach could improve prediction of who will get blood clots and help tailor prevention so fewer patients are over- or undertreated.
How similar studies have performed: Prior studies have shown increased NETs in MPN patients and links between NETosis and thrombosis, and aspirin can reduce NET formation, but prospective use of NETosis markers as a clinical prognostic tool remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe hepatic or renal insufficiency (Creatinine clearance \<30ml/min) * Patients under legal protection (guardianship or curatorship) * Patients under heparin treatment at inclusion
Where this trial is running
Angers and 14 other locations
- CHU d'Angers, Service des maladies du Sang — Angers, France (Not_yet_recruiting)
- CH de la Côte Basque, Service Hématologie — Bayonne, France (Not_yet_recruiting)
- CHU de Bordeaux, Service Hématologie Biologique — Bordeaux, France (Not_yet_recruiting)
- CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire — Bordeaux, France (Not_yet_recruiting)
- CHU de Brest, Service Hématologie et Hémostase Clinique — Brest, France (Not_yet_recruiting)
- APHP-Hôpital Mondor, Service Hématologie Clinique et Thérapie Cellulaire — Créteil, France (Not_yet_recruiting)
- CHD de Vendée, Service Onco-hématologie — La Roche-sur-Yon, France (Not_yet_recruiting)
- APHP-Hôpital Bicêtre, Service Hématologie Clinique Ambulatoire — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- CH de Libourne, Service Hématologie — Libourne, France (Recruiting)
- CHU de Limoges, Service Hématologie Clinique et de Thérapie Cellulaire — Limoges, France (Not_yet_recruiting)
- CH des Pays de Morlaix, Service Onco-Hématologie — Morlaix, France (Not_yet_recruiting)
- CHU de Nantes, Service Hématologie Clinique — Nantes, France (Not_yet_recruiting)
- Hôpital Privé du Confluent, Service Hématologie — Nantes, France (Not_yet_recruiting)
- APHO-Hôpital Saint-Louis, Centre d'Investigations Cliniques — Paris, France (Not_yet_recruiting)
- CH de Roubaix, Service Hématologie — Roubaix, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexandre GUY — alexandre.guy@chu-bordeaux.fr
- Study coordinator: Alexandre GUY
- Email: alexandre.guy@chu-bordeaux.fr
- Phone: 0557656478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.