Myeloproliferative Neoplasm Clinical Trial
— MICROP-SMPOfficial title:
Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of Chronic Philadelphia Negative Myeloproliferative Neoplasms
NCT number | NCT02862366 |
Other study ID # | RC-P0004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | January 25, 2016 |
Verified date | August 2018 |
Source | Lille Catholic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | January 25, 2016 |
Est. primary completion date | January 25, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria for MNPs patients: - Age > 18 - Establish MNPs Phi- diagnosis (ET, PV, MFP) - Consent to participate Inclusion Criteria for healthy volunteers: - 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.) - Not pregnant - Non smoker - For women, no hormonal contraceptives Exclusion Criteria for MNPs patients: - Pregnancy - Patient unable to give consent |
Country | Name | City | State |
---|---|---|---|
France | CHRU Lille | Lille | |
France | EFS | Lille | |
France | GHICL | Lille |
Lead Sponsor | Collaborator |
---|---|
Lille Catholic University |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the average number of microparticles detected by flow cytometry in all subgroup | Baseline |
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