- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912884
Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure (MPNClot)
Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. Thrombotic complications are the main determinant of morbidity and in a less extend mortality.
Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a hypercoagulable state. However, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state.
Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for PV and are under investigations on clinical trial for ET. It is currently unknown if treatments that were used for ET and PV, and especially JAKi are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs.
To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Geneva University Hospitals
-
-
-
-
-
London, United Kingdom, SE19RT
- Guy's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All men and women, older than 18 years, with a diagnosis of PV or ET (primary or secondary) according to the 2008 World Health Organization (WHO) classification.
Exclusion Criteria:
- Lack of participant's consent;
- Concomitant treatment with anticoagulant drugs (anti-vitamin K, heparin or direct oral anticoagulant drugs);
- Active cancer other than non-melanoma skin cancer (defined as cancer diagnosis <5 years or treatment <2 years);
- Recent infection (<30d);
- Recent surgery (<30d);
- Recent hospitalization (<30d);
- Recent thromboembolic or cardiovascular event (<3m).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PV
Patients with a diagnosis of polycythaemia vera.
|
No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).
|
ET
Patients with a diagnosis of essential thrombocythaemia.
|
No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fibrin polymerization; lag-time (in seconds)
Time Frame: At time of inclusion
|
Fibrin polymerization will be assessed by turbidity assay on plasma.
Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2.
Results will report lag-time (seconds).
|
At time of inclusion
|
Fibrin polymerization; maximal absorbance
Time Frame: At time of inclusion
|
Fibrin polymerization will be assessed by turbidity assay on plasma.
Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2.
Results will report maximal absorbance.
|
At time of inclusion
|
Clot lysis time (in minutes)
Time Frame: At time of inclusion
|
Fibrinolysis will be assessed by turbidity assay on plasma.
Fibrinolysis will be monitored by adding tissue plasminogen activator (tPA).
Results will report clot lysis time (minutes)
|
At time of inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clot permeation; permeation coefficient
Time Frame: At time of inclusion
|
Clot permeation will be reported as the calculated permeation coefficient (Ks).
|
At time of inclusion
|
Quantitative parameters of thrombin generation test (TGT); endogenous thrombin potential (nM*minutes)
Time Frame: At time of inclusion
|
The measurement of thrombin generation is performed by the technique of calibrated automated thrombogram (CAT).
Endogenous thrombin potential will be reported in nM*minutes.
|
At time of inclusion
|
Quantitative parameters of thrombin generation test (TGT); peak (nM)
Time Frame: At time of inclusion
|
The measurement of thrombin generation is performed by the technique of calibrated automated thrombogram (CAT).
Peak will be reported in nM.
|
At time of inclusion
|
Quantitative parameters of thrombin generation test (TGT); time to peak (minutes)
Time Frame: At time of inclusion
|
The measurement of thrombin generation is performed by the technique calibrated automated thrombogram (CAT).
Time to peak will be reported in minutes.
|
At time of inclusion
|
Fibrin density by laser scanner confocal microscopy (number per 100 μm)
Time Frame: At time of inclusion
|
The fibrin density was determined by counting the number of fibres crossing an arbitrary line of 100 μm drawn through a single optical section.
Each fibrin clot is prepared in duplicate and 20 density measurements were performed on each sample.
|
At time of inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yan Beauverd, University Hospital, Geneva
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCER 2016-00950
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycythemia Vera
-
PharmaEssentia Japan K.K.RecruitingPolycythemia Vera (PV)Japan
-
Novartis PharmaceuticalsCompletedPolycythemia Vera (PV)United States
-
PharmaEssentia Japan K.K.Recruiting
-
PharmaEssentia Japan K.K.CompletedPolycythemia Vera (PV)Japan
-
Memorial Sloan Kettering Cancer CenterEli Lilly and Company; Incyte CorporationRecruitingMyelofibrosis Due to and Following Polycythemia VeraUnited States
-
Ionis Pharmaceuticals, Inc.RecruitingPhlebotomy Dependent Polycythemia VeraUnited States, Canada, Hungary, United Kingdom, Australia, Poland
-
Northwestern UniversityNational Cancer Institute (NCI); Celgene; The Leukemia and Lymphoma SocietyWithdrawnPrimary Myelofibrosis | Polycythemia Vera, Post-Polycythemic Myelofibrosis PhaseUnited States
-
Novartis PharmaceuticalsTerminatedPrimary Myelofibrosis | Post-Polycythemia Vera | Post-Essential ThrombocytopeniaUnited States
-
CelgeneRecruitingPrimary Myelofibrosis | Myeloproliferative Disorders | Anemia | Myelofibrosis | Post-Polycythemia Vera MyelofibrosisFrance, Belgium, Austria, Spain, Australia, Canada, Japan, United States, Korea, Republic of, Romania, Israel, Italy, China, Czechia, Germany, Greece, Ireland, Poland, United Kingdom, Hong Kong, Hungary, Lebanon, Colombia, Argentina, Chile and more
-
CelgeneImpact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationActive, not recruitingPrimary Myelofibrosis | Myelofibrosis | Post-Polycythemia VeraAustralia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Ireland, United Kingdom
Clinical Trials on No cytoreductive vs cytoreductive drugs
-
NHS GrampianBarts & The London NHS Trust; Queen Mary University of London; University of...RecruitingOvarian CancerUnited Kingdom
-
Korea University Guro HospitalYonsei University; Boryung Pharmaceutical Co., Ltd; Chong Kun Dang Pharmaceutical...RecruitingOvarian Cancer | Drug Related Neoplasm/CancerKorea, Republic of
-
Hospices Civils de LyonCompletedGastric Cancer | Peritoneal CarcinomatosisFrance
-
Women's Hospital School Of Medicine Zhejiang UniversityNot yet recruiting
-
M.D. Anderson Cancer CenterRecruiting
-
University Hospital, BonnUnknown
-
Hospices Civils de LyonCompletedOvarian Cancer | Peritoneal CarcinomaFrance
-
Eastern Hepatobiliary Surgery HospitalCompletedHepatocellular CarcinomaChina
-
Shanghai Gynecologic Oncology GroupZhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Shanghai Zhongshan...Active, not recruitingFallopian Tube Carcinoma | Ovarian Epithelial Cancer Recurrent | Primary Peritoneal CarcinomaChina
-
Zagazig UniversityCompleted