Myeloproliferative NeoplasmMICROP-SMPNCT02862366
Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-
An observational study of Myeloproliferative Neoplasm, run by Lille Catholic University at 3 sites in France.
Trial summary
Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Blood sampling
- How many people
- 128 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2010to 25 Jan 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ET, PV or PMF. Healthy volunteers.
Who may be able to join
- Age > 18
- Establish MNPs Phi- diagnosis (ET, PV, MFP)
- Consent to participate
- Healthy volunteers matched in age, sex with the MNPs patients, with a normal complete blood and platelet count
- No personal thromboembolic history
- No known thromboembolic risk factor : thrombophilia, cancers, and other disease associated with a thrombotic risk (Atrial fibrillation, etc.)
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- Not pregnant
- Non smoker
- For women, no hormonal contraceptives
Who cannot join
- Pregnancy
- Patient unable to give consent
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms
Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.
These last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Blood sampling
- Keywords
- myeloproliferative neoplasms, Circulating Procoagulants Microparticles
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling every 6 month following the routine calendar of visit
| Study group | Role | What they receive |
|---|---|---|
| Primary Myelofibrosis (PMF) | Blood sampling during routine visit Receives: Other: Blood sampling | |
| Essential thrombocytosis (ET) | Blood sampling during routine visit Receives: Other: Blood sampling | |
| Polycythemia vera (PV) | Blood sampling during routine visit Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the average number of microparticles detected by flow cytometry in all subgroup
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startOct 2010
- Primary completion25 Jan 2016
- Study completion25 Jan 2016
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.
- 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès Charpentier, MD, PhD, Study director, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862366
- Sponsor's protocol ID
- RC-P0004
- Acronym
- MICROP-SMP
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2016
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT02862366
- Acronym / sponsor ID
- MICROP-SMP / RC-P0004
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- myeloproliferative neoplasms, Circulating Procoagulants Microparticles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 25 Jan 2016 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein thrombosis. This is responsible for a significant increase in mortality (up to 31% of increase in thrombosis risk in ET). Cellular inflation and blood hyperviscosity, resulting from these diseases, fail to account for these thromboses, as more than 50% of thrombotic complications happen under adapted antineoplastic drug treatment.
These last years, cellular microparticles (MPs) have been shown to play a major role in thrombogenesis. MPs are generated by apoptosis or the activation of malignant cells, platelets, endothelial cells or monocytes. They are fragments of plasma membrane, smaller than 1 µm, rich in phosphatidylserine, which can express the tissue factor and serve as support for the coagulation factors. Increase in the plasma concentration of procoagulant platelet microparticles has been demonstrated in other thrombotic diseases (acute coronary syndrome, disseminated intravascular coagulation DIC, etc.). The working hypothesis is that platelet microparticles are involved in the hypercoagulability of MPNs patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Myelofibrosis (PMF) | – | Other: Blood samplingBlood sampling during routine visit |
| Essential thrombocytosis (ET) | – | Other: Blood samplingBlood sampling during routine visit |
| Polycythemia vera (PV) | – | Other: Blood samplingBlood sampling during routine visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ET, PV or PMF. Healthy volunteers.
Key inclusion criteria (9 listed)
- Age > 18
- Establish MNPs Phi- diagnosis (ET, PV, MFP)
- Consent to participate
- Healthy volunteers matched in age, sex with the MNPs patients, with a normal complete blood and platelet count
- No personal thromboembolic history
Key exclusion criteria (2 listed)
- Pregnancy
- Patient unable to give 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 |
|---|---|---|
| Blood samplingBlood sampling every 6 month following the routine calendar of visit | Other | Essential thrombocytosis (ET), Polycythemia vera (PV), Primary Myelofibrosis (PMF) |
Primary outcome
Comparison of the average number of microparticles detected by flow cytometry in all subgroup
Time frame: Baseline
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 31 Oct 2018.
- 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.
Agnès Charpentier, MD, PhD study director
GHICL
3 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 Lille Catholic University at 3 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 9 inclusion and 2 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Comparison of the average number of microparticles detected by flow cytometry in all subgroup (time frame: Baseline). 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 31 Oct 2018.