Myeloproliferative NeoplasmMPN-BIOCLOTNCT04177576
Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Bordeaux at 24 sites in France.
Trial summary
Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- 2 additional tubes of blood
- How many people
- 397 participants
- Where
- 24 sitesFrance
- Study dates
- 24 Feb 2020to 26 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with myeloproliferative neoplasms (MPN), diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET)
Who may be able to join
- Adults (age ≥18 years),
- Patients diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET) according to WHO 2008 criteria,
- Affiliated to the national social security system,
- Signed informed consent form will be required for each included subject after having read the information note,
- Patient agreeing to be included in the FIMBANK register and having signed the corresponding consent
Who cannot join
- Adults (age >18 years), male or female,
- Patients treated with heparin or undergoing cytoreductive treatment,
- Pregnant or lactating woman,
- Person under guardianship, tutorship or other legal protection scheme or incapable of giving consent
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
CHU Angers
Angers
CH Annecy Genevois
Annecy
CH Avignon
Avignon
CHU Bordeaux, Hématologie Biologique
Bordeaux
CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire
Bordeaux
CHU Bordeaux, Médecine Interne
Bordeaux
Institut Bergonié
Bordeaux
CHRU Brest
Brest
CHU Henri Mondor - APHP
Créteil
CH Dax
Dax
CHU Dijon
Dijon
CHU Limoges
Limoges
Centre Léon Bérard
Lyon
CH Mont de Marsan
Mont-de-Marsan
CHU Nancy
Nancy
Hôpital Européen Georges Pompidou - APHP
Paris
Hôpital Saint-Louis - APHP
Paris
CH Perpignan
Perpignan
CHU Poitiers
Poitiers
CH Rochefort
Rochefort
CH Roubaix
Roubaix
IUCT-Oncopôle
Toulouse
CH Valenciennes
Valenciennes
Hôpital Paul Brousse
Villejuif
About this study
Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.
Read the detailed description
Myeloproliferative neoplasms (MPN) are acquired clonal hematopoietic stem cell disorders, characterized by an increase in one or more myeloid lineages. The Philadelphia chromosome negative (Ph-) MPN include polycythemia vera (PV) with an excess of red blood cells, essential thrombocythemia (ET) with an increase in platelets and primary myelofibrosis (PMF). Arterial and venous thromboses are the main causes of morbidity and mortality in MPN with reported incidences ranging from 12-39% in PV and 11-25% in ET. The pathogenesis of thrombosis in MPN patients is complex and still largely elusive. The overproduction of neutrophils could be an important risk factor in the thrombus formation. Indeed neutrophils are known to promote thrombosis when they release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". Increased NETosis has been reported in a mouse model of MPN. The main objective of this study is to investigate whether NET biomarkers are associated with increased thrombotic risk in patients with ET. Indeed, an international thrombotic prognostic score has been published in ET, ie the IPSET Thrombosis score (history of thrombosis, age, presence of JAK2V617F, cardiovascular risk factors).
Plasma from MPN patients will be collected, at the time of diagnosis, and measure markers of neutrophil activation, including NET biomarkers. The IPSET Thrombosis score will be evaluated in patients with ET and the correlation between the IPSET Thrombosis score and these biomarkers will be measured.
No follow-up is required for this study.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- 2 additional tubes of blood
- Keywords
- Polycythemia Vera (PV), Essential Thrombocythemia (ET), Neutrophil Extracellular Trap (NET), Thrombosis
- Medical subject headings
- Myeloproliferative Disorders, Polycythemia Vera, Thrombocythemia, Essential, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 additional tubes of bloodBiological
2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation
| Study group | Role | What they receive |
|---|---|---|
| Patients with myeloproliferative neoplasms (MPN) | Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Receives: Biological: 2 additional tubes of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between NET biomarkers and the risk of thrombosis
Correlation between NET biomarkers measurated in plasma samples and the risk of thrombosis evaluated by the prognostic score IPSET thrombosis
Measured: 1 day
Secondary outcomes (3)
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis
Measured: 1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the subtype of MPN disease (ET or PV)
Measured: 1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start24 Feb 2020
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé JAMES, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177576
- Sponsor's protocol ID
- CHUBX 2018/50
- Acronym
- MPN-BIOCLOT
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2019
- Last updated
- 6 Oct 2022
- 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 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT04177576
- Acronym / sponsor ID
- MPN-BIOCLOT / CHUBX 2018/50
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- Polycythemia Vera (PV), Essential Thrombocythemia (ET), Neutrophil Extracellular Trap (NET), Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 26 Nov 2019 (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.
Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.
Detailed description
Myeloproliferative neoplasms (MPN) are acquired clonal hematopoietic stem cell disorders, characterized by an increase in one or more myeloid lineages. The Philadelphia chromosome negative (Ph-) MPN include polycythemia vera (PV) with an excess of red blood cells, essential thrombocythemia (ET) with an increase in platelets and primary myelofibrosis (PMF). Arterial and venous thromboses are the main causes of morbidity and mortality in MPN with reported incidences ranging from 12-39% in PV and 11-25% in ET. The pathogenesis of thrombosis in MPN patients is complex and still largely elusive. The overproduction of neutrophils could be an important risk factor in the thrombus formation. Indeed neutrophils are known to promote thrombosis when they release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". Increased NETosis has been reported in a mouse model of MPN. The main objective of this study is to investigate whether NET biomarkers are associated with increased thrombotic risk in patients with ET. Indeed, an international thrombotic prognostic score has been published in ET, ie the IPSET Thrombosis score (history of thrombosis, age, presence of JAK2V617F, cardiovascular risk factors).
Plasma from MPN patients will be collected, at the time of diagnosis, and measure markers of neutrophil activation, including NET biomarkers. The IPSET Thrombosis score will be evaluated in patients with ET and the correlation between the IPSET Thrombosis score and these biomarkers will be measured.
No follow-up is required for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with myeloproliferative neoplasms (MPN) | – | Biological: 2 additional tubes of bloodPatients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myeloproliferative neoplasms (MPN), diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET)
Key inclusion criteria (5 listed)
- Adults (age ≥18 years),
- Patients diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET) according to WHO 2008 criteria,
- Affiliated to the national social security system,
- Signed informed consent form will be required for each included subject after having read the information note,
- Patient agreeing to be included in the FIMBANK register and having signed the corresponding consent
Key exclusion criteria (4 listed)
- Adults (age >18 years), male or female,
- Patients treated with heparin or undergoing cytoreductive treatment,
- Pregnant or lactating woman,
- Person under guardianship, tutorship or other legal protection scheme or incapable of giving consent
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 |
|---|---|---|
| 2 additional tubes of blood2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation | Biological | Patients with myeloproliferative neoplasms (MPN) |
Primary outcome
Correlation between NET biomarkers and the risk of thrombosis
Time frame: 1 day
Correlation between NET biomarkers measurated in plasma samples and the risk of thrombosis evaluated by the prognostic score IPSET thrombosis
3 secondary outcomes
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis
Time frame: 1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the subtype of MPN disease (ET or PV)
Time frame: 1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- 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. This study is not recruiting at the moment.
Chloé JAMES principal investigator
University Hospital, Bordeaux
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by University Hospital, Bordeaux at 24 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between NET biomarkers and the risk of thrombosis (time frame: 1 day). 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 6 Oct 2022.