Myeloproliferative NeoplasmAVATARENCT07119970
Prognostic Value of NETosis Markers for Thrombosis During Myeloproliferative Neoplasms (AVATARE)
A study testing Additional blood sampling in people with Myeloproliferative Neoplasm and Myeloproliferative Disorders, run by University Hospital, Bordeaux at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Myeloproliferative Disorders
- What is being tested?
- Additional blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesFrance
- Study dates
- 9 Dec 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe hepatic or renal insufficiency (Creatinine clearance <30ml/min)
- Patients under legal protection (guardianship or curatorship)
- Patients under heparin treatment at inclusion
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Not yet recruiting
CHU d'Angers, Service des maladies du Sang
Angers, 49933
Corentin ORVAIN, corentin.orvain@chu-angers.fr
- Not yet recruiting
CH de la Côte Basque, Service Hématologie
Bayonne, 64100
Frédéric BAUDUER, fbauduer@ch-cotebasque.fr
- Not yet recruiting
CHU de Bordeaux, Service Hématologie Biologique
Bordeaux, 33600
Alexandre GUY, alexandre.guy@chu-bordeaux.fr
- Not yet recruiting
CHU de Bordeaux, Service Hématologie Clinique et Thérapie Cellulaire
Bordeaux, 33600
Clémence MEDIAVILLA, clemence.mediavilla@chu-bordeaux.fr
- Not yet recruiting
CHU de Brest, Service Hématologie et Hémostase Clinique
Brest, 29609
Jean-Christophe IANOTTO, jean-christophe.ianotto@chu-brest.fr
- Not yet recruiting
APHP-Hôpital Mondor, Service Hématologie Clinique et Thérapie Cellulaire
Créteil, 94010
Lydia ROY, lydia.roy@aphp.fr
- Not yet recruiting
CHD de Vendée, Service Onco-hématologie
La Roche-sur-Yon, 85925
Bruno VILLEMAGNE, bruno.villemagne@ght85.fr
- Not yet recruiting
APHP-Hôpital Bicêtre, Service Hématologie Clinique Ambulatoire
Le Kremlin-Bicêtre, 94270
Laurence LEGROS, laurence.legros@aphp.fr
- Recruiting
CH de Libourne, Service Hématologie
Libourne, 33505
Diane LARA, diane.lara@ch-libourne.fr
- Not yet recruiting
CHU de Limoges, Service Hématologie Clinique et de Thérapie Cellulaire
Limoges, 87042
Amélie PENOT, amelie.penot@chu-limoges.fr
- Not yet recruiting
CH des Pays de Morlaix, Service Onco-Hématologie
Morlaix, 29672
Christophe NICOL, cnicol@ch-morlaix.fr
- Not yet recruiting
CHU de Nantes, Service Hématologie Clinique
Nantes, 44093
Viviane DUBRUILLE, viviane.dubruille@chu-nantes.fr
- Not yet recruiting
Hôpital Privé du Confluent, Service Hématologie
Nantes, 44202
Katell LE DU, dr.ledu@groupeconfluent.fr
- Not yet recruiting
APHO-Hôpital Saint-Louis, Centre d'Investigations Cliniques
Paris, 75010
Juliette SORET-DULPHY, juliette.soret@aphp.fr
- Not yet recruiting
CH de Roubaix, Service Hématologie
Roubaix, 59100
Mathieu WEMEAU, mathieu.wemeau@ch-roubaix.fr
About this study
Official title: Prospective Study for the Evaluation of the Prognostic Value of NETosis Markers to Predict Thrombosis in Myeloproliferative Neoplasms With JAK2V617F Mutation (AVATARE)
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.
Read the detailed description
JAK2V617F positive myeloproliferative neoplasms (MPNs) are clonal disorders of hematopoietic stem cells characterized by an increased risk of thrombosis, the main cause of morbidity and mortality in these patients. Classical risk factors for thrombosis include a prior thrombotic event and age over 60. However, these criteria are often insufficient, as some patients who receive treatment continue to experience thrombosis, while others may be overtreated based solely on age. Recent studies have highlighted the role of neutrophil extracellular traps (NETs) in thrombosis, suggesting that NETosis, the process of NET formation, contributes to the activation of hemostasis and coagulation. Increased levels of NETs have been observed in patients with MPNs, particularly those with a history of thrombosis. Aspirin has shown a potential to reduce NET formation and the occurrence of thrombosis by inhibiting platelet-triggered NETosis. This study aims to prospectively evaluate the prognostic value of NETosis markers to predict thrombosis and optimize thrombotic prevention strategies in JAK2V617F-positive MPN patients.
The AVATARE ancillary study is linked to the AVAJAK clinical trial, which compares the efficacy of aspirin versus direct oral anticoagulants (DOACs) in preventing thrombotic events. Patients included in the AVATARE study will undergo venous blood sampling at baseline (T0) and 12 months (T1) for NETosis markers, such as calprotectin and citrullinated histone H3 (H3Cit). Participants will be followed up for 24 months. Clinical data, including the occurrence of venous and arterial thrombotic events, will be collected during the study period. Blood samples will be taken at inclusion (T0) and at 12 months (T1). The progression of NETosis markers will be monitored, and their correlation with thrombotic outcomes will be assessed to understand the potential role of these markers in predicting future thrombotic events.
- Being tested
- Additional blood sampling
- Keywords
- Myeloproliferative neoplasms, Thrombosis, Neutrophil extracellular traps, Neutrophils
- Medical subject headings
- Myeloproliferative Disorders, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplingBiological
At inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis
| Study group | Role | What they receive |
|---|---|---|
| Direct oral anticoagulants (DOACs) | Experimental | Not described Receives: Biological: Additional blood sampling |
| Aspirin | Active comparator | Not described Receives: Biological: Additional blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At T0 (inclusion)
Secondary outcomes (4)
Serum calprotectin concentration
Measured: At T1 (12 months post-inclusion)
Serum concentration of citrullinated histone H3 (H3Cit)
This concentration will be assessed to evaluate calprotectin concentration at T1 and to compare the evolution of this marker in patients treated by direct oral anticoagulant or by aspirin.
Measured: At T1 (12 months post-inclusion)
Plasma citrullinated histone 3 concentration
This concentration will be compared between MPN patients who develop thrombotic events during the follow-up and those who do not. The plasma concentration will be measured using ELISA test and the results will be analyzed to assess its association with future thrombotic events in patients with myeloproliferative neoplasms.
Measured: At T0 (inclusion)
Plasma citrullinated histone 3 concentration
This concentration will be assessed to evaluate citrullinated histone 3 concentration at T1 and to compare the evolution of this marker in patients treated by direct oral anticoagulant or by aspirin.
Measured: At T1 (12 months post-inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start9 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre GUY, Principal investigator, alexandre.guy@chu-bordeaux.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119970
- Sponsor's protocol ID
- CHUBX 2023/91
- Acronym
- AVATARE
- Status last verified
- Jan 2026
- First submitted
- 1 Jul 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for the Evaluation of the Prognostic Value of NETosis Markers to Predict Thrombosis in Myeloproliferative Neoplasms With JAK2V617F Mutation (AVATARE)
- ClinicalTrials.gov ID
- NCT07119970
- Acronym / sponsor ID
- AVATARE / CHUBX 2023/91
- Keywords
- Myeloproliferative neoplasms, Thrombosis, Neutrophil extracellular traps, Neutrophils
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
JAK2V617F positive myeloproliferative neoplasms (MPNs) are clonal disorders of hematopoietic stem cells characterized by an increased risk of thrombosis, the main cause of morbidity and mortality in these patients. Classical risk factors for thrombosis include a prior thrombotic event and age over 60. However, these criteria are often insufficient, as some patients who receive treatment continue to experience thrombosis, while others may be overtreated based solely on age. Recent studies have highlighted the role of neutrophil extracellular traps (NETs) in thrombosis, suggesting that NETosis, the process of NET formation, contributes to the activation of hemostasis and coagulation. Increased levels of NETs have been observed in patients with MPNs, particularly those with a history of thrombosis. Aspirin has shown a potential to reduce NET formation and the occurrence of thrombosis by inhibiting platelet-triggered NETosis. This study aims to prospectively evaluate the prognostic value of NETosis markers to predict thrombosis and optimize thrombotic prevention strategies in JAK2V617F-positive MPN patients.
The AVATARE ancillary study is linked to the AVAJAK clinical trial, which compares the efficacy of aspirin versus direct oral anticoagulants (DOACs) in preventing thrombotic events. Patients included in the AVATARE study will undergo venous blood sampling at baseline (T0) and 12 months (T1) for NETosis markers, such as calprotectin and citrullinated histone H3 (H3Cit). Participants will be followed up for 24 months. Clinical data, including the occurrence of venous and arterial thrombotic events, will be collected during the study period. Blood samples will be taken at inclusion (T0) and at 12 months (T1). The progression of NETosis markers will be monitored, and their correlation with thrombotic outcomes will be assessed to understand the potential role of these markers in predicting future thrombotic events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct oral anticoagulants (DOACs) | Experimental | Biological: Additional blood sampling |
| Aspirin | Active comparator | Biological: Additional blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Severe hepatic or renal insufficiency (Creatinine clearance <30ml/min)
- Patients under legal protection (guardianship or curatorship)
- Patients under heparin treatment at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional blood samplingAt inclusion (T0) and at 12 months (T1), venous blood will be drawn for plasma markers of NETosis | Biological | Aspirin, Direct oral anticoagulants (DOACs) |
Primary outcome
Serum calprotectin concentration
Time frame: At T0 (inclusion)
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.
4 secondary outcomes
Serum calprotectin concentration
Time frame: At T1 (12 months post-inclusion)
Serum concentration of citrullinated histone H3 (H3Cit)
Time frame: At T1 (12 months post-inclusion)
Plasma citrullinated histone 3 concentration
Time frame: At T0 (inclusion)
Plasma citrullinated histone 3 concentration
Time frame: At T1 (12 months post-inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre GUY principal investigator
alexandre.guy@chu-bordeaux.fr
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional blood sampling in people with Myeloproliferative Neoplasm and Myeloproliferative Disorders, run by University Hospital, Bordeaux at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre GUY (0557656478, alexandre.guy@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum calprotectin concentration (time frame: At T0 (inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.