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Clinical Trial Finder

Search Results

Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms

Study Purpose

Thrombosis is the main cause of morbidity and mortality in patients with myeloproliferative neoplasms (MPN). However, the pathogenesis of thrombosis in MPN is still largely elusive. Neutrophils can release their decondensed chromatin as a network of extracellular fibers named NET for "neutrophils extracellular trap". NETs are known to be procoagulant. Our main objective is to quantify NETs biomarkers expression in MPN patients and define if they could be used as prognostic factors in the outcome of thrombosis in these patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04177576
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Bordeaux
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chloé JAMES
Principal Investigator Affiliation University Hospital, Bordeaux
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloproliferative Neoplasm
Additional Details

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.

Arms & Interventions

Arms

: Patients with myeloproliferative neoplasms (MPN)

Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET)

Interventions

Biological: - 2 additional tubes of blood

2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Angers, Angers, France

Status

Recruiting

Address

CHU Angers

Angers, ,

Site Contact

Françoise BOYER

Frboyer-perrard@chu-angers.fr

+33 (0)5 57 65 64 78

CH Annecy Genevois, Annecy, France

Status

Recruiting

Address

CH Annecy Genevois

Annecy, ,

Site Contact

Pascale CONY-MAKHOUL

pconymakhoul@ch-annecygenevois.fr

+33 (0)5 57 65 64 78

CH Avignon, Avignon, France

Status

Recruiting

Address

CH Avignon

Avignon, ,

Site Contact

Borhane SLAMA

bslama@ch-avignon.fr

+33 (0)5 57 65 64 78

CHU Bordeaux, Hématologie Biologique, Bordeaux, France

Status

Recruiting

Address

CHU Bordeaux, Hématologie Biologique

Bordeaux, ,

Site Contact

Cholé JAMES

chloe.james@chu-bordeaux.fr

+33 (0)5 57 65 64 78

Bordeaux, France

Status

Recruiting

Address

CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire

Bordeaux, ,

Site Contact

Axelle LASCAUX

axelle.lascaux@chu-bordeaux.fr

+33 (0)5 57 65 64 78

CHU Bordeaux, Médecine Interne, Bordeaux, France

Status

Not yet recruiting

Address

CHU Bordeaux, Médecine Interne

Bordeaux, ,

Site Contact

Jean-François VIALLARD

jean-francois.viallard@chu-bordeaux.fr

+33 (0)5 57 65 64 78

Institut Bergonié, Bordeaux, France

Status

Recruiting

Address

Institut Bergonié

Bordeaux, ,

Site Contact

Gabriel ETIENNE

G.Etienne@bordeaux.unicancer.fr

+33 (0)5 57 65 64 78

CHRU Brest, Brest, France

Status

Not yet recruiting

Address

CHRU Brest

Brest, ,

Site Contact

Jean-Christophe IANOTTO

jean-christophe.ianotto@chu-brest.fr

+33 (0)5 57 65 64 78

CHU Henri Mondor - APHP, Créteil, France

Status

Recruiting

Address

CHU Henri Mondor - APHP

Créteil, ,

Site Contact

Lydia ROY

lydia.roy@aphp.fr

+33 (0)5 57 65 64 78

CH Dax, Dax, France

Status

Not yet recruiting

Address

CH Dax

Dax, ,

Site Contact

François LIFERMANN

lifermannf@ch-dax.fr

+33 (0)5 57 65 64 78

CHU Dijon, Dijon, France

Status

Not yet recruiting

Address

CHU Dijon

Dijon, ,

Site Contact

François GIRODON

francois.girodon@chu-dijon.fr

+33 (0)5 57 65 64 78

CHU Limoges, Limoges, France

Status

Recruiting

Address

CHU Limoges

Limoges, ,

Site Contact

Stéphane GIRAULT

stephane.girault@chu-limoges.fr

+33 (0)5 57 65 64 78

Centre Léon Bérard, Lyon, France

Status

Recruiting

Address

Centre Léon Bérard

Lyon, ,

Site Contact

Franck-Emmanuel NICOLINI

franck-emmanuel.nicolini@lyon.unicancer.fr

+33 (0)5 57 65 64 78

CH Mont de Marsan, Mont-de-Marsan, France

Status

Recruiting

Address

CH Mont de Marsan

Mont-de-Marsan, ,

Site Contact

Arnaud SAINT LEZER

arnaud.saint-lezer@ch-mdm.fr

+33 (0)5 57 65 64 78

CHU Nancy, Nancy, France

Status

Not yet recruiting

Address

CHU Nancy

Nancy, ,

Site Contact

Dana RANTA

d.ranta@chu-nancy.fr

+33 (0)5 57 65 64 78

Hôpital Européen Georges Pompidou - APHP, Paris, France

Status

Recruiting

Address

Hôpital Européen Georges Pompidou - APHP

Paris, ,

Site Contact

Luc DARNIGE

luc.darnige@aphp.fr

+33 (0)5 57 65 64 78

Hôpital Saint-Louis - APHP, Paris, France

Status

Recruiting

Address

Hôpital Saint-Louis - APHP

Paris, ,

Site Contact

Jean-Jacques KILADJIAN

jean-jacques.kiladjian@aphp.fr

+33 (0)5 57 65 64 78

Hôpital Tenon - APHP, Paris, France

Status

Not yet recruiting

Address

Hôpital Tenon - APHP

Paris, ,

Site Contact

Loula PAPAGEORGIOU

loula.papageorgiou@aphp.fr

+33 (0)5 57 65 64 78

CH Perpignan, Perpignan, France

Status

Recruiting

Address

CH Perpignan

Perpignan, ,

Site Contact

Fabienne VACHERET

fabienne.vacheret@ch-perpignan.fr

+33 (0)5 57 65 64 78

CHU Poitiers, Poitiers, France

Status

Recruiting

Address

CHU Poitiers

Poitiers, ,

Site Contact

Emilie CAYSSIALS

Emilie.CAYSSIALS@chu-poitiers.fr

+33 (0)5 57 65 64 78

CH Rochefort, Rochefort, France

Status

Recruiting

Address

CH Rochefort

Rochefort, ,

Site Contact

Guillaume DENIS

guillaume.denis@ch-rochefort.fr

+33 (0)5 57 65 64 78

CH Roubaix, Roubaix, France

Status

Not yet recruiting

Address

CH Roubaix

Roubaix, ,

Site Contact

Mathieu WEMEAU

mathieu.wemeau@ch-roubaix.fr

+33 (0)5 57 65 64 78

IUCT-Oncopôle, Toulouse, France

Status

Recruiting

Address

IUCT-Oncopôle

Toulouse, ,

Site Contact

Suzanne TAVITIAN

tavitian.suzanne@iuctoncopole.fr

+33 (0)5 57 65 64 78

CH Valenciennes, Valenciennes, France

Status

Recruiting

Address

CH Valenciennes

Valenciennes, ,

Site Contact

Nathalie CAMBIER

cambier-n@ch-valenciennes.fr

+33 (0)5 57 65 64 78

Hôpital Paul Brousse, Villejuif, France

Status

Recruiting

Address

Hôpital Paul Brousse

Villejuif, ,

Site Contact

Laurence GROS

Laurence.legros@aphp.fr

+33 (0)5 57 65 64 78

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