Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-

NCT02862366 | Completed

• 1 other identifier: RC-P0004
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

myeloproliferative neoplasms; Circulating Procoagulants Microparticles

Outcome Measures

Primary Outcomes (1)

• Comparison of the average number of microparticles detected by flow cytometry in all subgroup

  Baseline

Study Arms (3)

Primary Myelofibrosis (PMF)

Blood sampling during routine visit

Other: Blood sampling

Essential thrombocytosis (ET)

Blood sampling during routine visit

Other: Blood sampling

Polycythemia vera (PV)

Blood sampling during routine visit

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling every 6 month following the routine calendar of visit

Essential thrombocytosis (ET); Polycythemia vera (PV); Primary Myelofibrosis (PMF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ET, PV or PMF. Healthy volunteers.

You may qualify if:

• 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.)
• Not pregnant
• Non smoker
• For women, no hormonal contraceptives

You may not qualify if:

• Pregnancy
• Patient unable to give consent

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (3)

EFS

Lille, 59000, France

Location

GHICL

Lille, 59000, France

Location

CHRU Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Agnès Charpentier, MD, PhD

  GHICL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 11, 2016
• Study Start: October 1, 2010
• Primary Completion: January 25, 2016
• Study Completion: January 25, 2016
• Last Updated: October 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)