- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177576
Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms (MPN-BIOCLOT)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Angers, France
- CHU Angers
-
Annecy, France
- Ch Annecy Genevois
-
Avignon, France
- CH Avignon
-
Bordeaux, France
- Institut Bergonié
-
Bordeaux, France
- CHU Bordeaux, Hématologie Biologique
-
Bordeaux, France
- CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire
-
Bordeaux, France
- CHU Bordeaux, Médecine Interne
-
Brest, France
- CHRU Brest
-
Créteil, France
- CHU Henri Mondor - APHP
-
Dax, France
- CH Dax
-
Dijon, France
- CHU Dijon
-
Limoges, France
- CHU Limoges
-
Lyon, France
- Centre Leon Berard
-
Mont-de-Marsan, France
- CH Mont de Marsan
-
Nancy, France
- Chu Nancy
-
Paris, France
- Hôpital européen Georges Pompidou - APHP
-
Paris, France
- Hopital Saint-Louis - APHP
-
Perpignan, France
- CH Perpignan
-
Poitiers, France
- CHU Poitiers
-
Rochefort, France
- CH Rochefort
-
Roubaix, France
- CH Roubaix
-
Toulouse, France
- IUCT-Oncopole
-
Valenciennes, France
- CH Valenciennes
-
Villejuif, France
- Hôpital Paul Brousse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with myeloproliferative neoplasms (MPN)
Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET)
|
2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis
Time Frame: 1 day
|
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
|
1 day
|
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chloé JAMES, University Hospital, Bordeaux
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 (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2018/50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Myeloproliferative Neoplasm
-
Sociedad de Lucha Contra el Cáncer del EcuadorCompletedMyeloproliferative Disorders | Myeloproliferative Neoplasm | Myeloproliferative Syndrome | Myeloproliferative Neoplasm, Unclassifiable | Myeloproliferative Disease, Not ClassifiedEcuador
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or AnemiaAnemia | Myelofibrosis | Myelodysplastic/Myeloproliferative NeoplasmUnited States
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedMyelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified | Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise SpecifiedUnited States
-
Astex Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterNot yet recruitingMyeloproliferative Neoplasm | Myelodysplastic Neoplasm | Pathway Mutant Myelodysplastic SyndromesUnited States
-
ImmunoGen, Inc.Active, not recruitingBlastic Plasmacytoid Dendritic Cell Neoplasm | Myeloproliferative NeoplasmUnited States, Spain, Germany, Italy, France, United Kingdom
-
Fred Hutchinson Cancer CenterImmunoGen, Inc.RecruitingAcute Myeloid Leukemia | Myelodysplastic Syndrome | Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative Neoplasm | Mixed Phenotype Acute LeukemiaUnited States
-
BeiGeneRecruitingAcute Myeloid Leukemia | Myelodysplastic Syndromes | Myelodysplastic/Myeloproliferative NeoplasmChina, United States, Australia, Spain, Korea, Republic of, New Zealand, Germany
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAcute Myeloid Leukemia | Myelodysplastic Syndrome | Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative NeoplasmUnited States
-
AUSL Romagna RiminiCompleted
Clinical Trials on 2 additional tubes of blood
-
Centre Hospitalier Universitaire de NiceBio-Rad LaboratoriesCompletedSepsisFrance, Monaco
-
Centre Hospitalier Universitaire de NiceRecruitingNew Coronavirus Disease (COVID-19), Infection With SARS-CoV-2France
-
Institut Paoli-CalmettesINSERM-U1068RecruitingMalignant HemopathyFrance
-
Assistance Publique - Hôpitaux de ParisUnknownDiabetes type2 | NAFLD | NASH - Nonalcoholic Steatohepatitis
-
University Hospital, BordeauxCompletedPremature Delivery
-
Rennes University HospitalCompleted
-
University Hospital, BordeauxNot yet recruitingInfluenza | Acute Respiratory Distress SyndromeFrance
-
Centre Hospitalier Universitaire DijonUnknownObesity | Overweight | Type 2 DiabetesFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
Centre Hospitalier Universitaire de NiceCompleted