Evaluation of New Biomarkers of Thrombosis in Myeloproliferative Neoplasms
MPN-BIOCLOT
1 other identifier
observational
397
1 country
24
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
February 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedOctober 6, 2022
October 1, 2022
1.9 years
October 30, 2019
October 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between NET biomarkers and the risk of thrombosis
Correlation between NET biomarkers measurated in plasma samples and the risk of thrombosis evaluated by the prognostic score IPSET thrombosis
1 day
Secondary Outcomes (3)
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and a history of thrombosis
1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the subtype of MPN disease (ET or PV)
1 day
Correlation between MPO-DNA levels (measured by absorbance at 405 nm) and the presence of JAK2V617F mutation
1 day
Study Arms (1)
Patients with myeloproliferative neoplasms (MPN)
Patients diagnosed with Polycythemia Vera (PV) or Essential Thrombocythemia (ET)
Interventions
2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation
Eligibility Criteria
Patients with myeloproliferative neoplasms (MPN), diagnosed with Polycythemia vera (PV) or essential thrombocythemia (ET)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
CHU Angers
Angers, France
CH Annecy Genevois
Annecy, France
CH Avignon
Avignon, France
CHU Bordeaux, Hématologie Biologique
Bordeaux, France
CHU Bordeaux, Hématologie Clinique et Thérapie Cellulaire
Bordeaux, France
CHU Bordeaux, Médecine Interne
Bordeaux, France
Institut Bergonié
Bordeaux, France
CHRU Brest
Brest, France
CHU Henri Mondor - APHP
Créteil, France
CH Dax
Dax, France
CHU Dijon
Dijon, France
CHU Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
CH Mont de Marsan
Mont-de-Marsan, France
CHU Nancy
Nancy, France
Hôpital Européen Georges Pompidou - APHP
Paris, France
Hôpital Saint-Louis - APHP
Paris, France
CH Perpignan
Perpignan, France
CHU Poitiers
Poitiers, France
CH Rochefort
Rochefort, France
CH Roubaix
Roubaix, France
IUCT-Oncopôle
Toulouse, France
CH Valenciennes
Valenciennes, France
Hôpital Paul Brousse
Villejuif, France
Biospecimen
Plasma aliquots
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chloé JAMES
University Hospital, Bordeaux
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 26, 2019
Study Start
February 24, 2020
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
October 6, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share