Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

Study Overview
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Brief Summary
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The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.

Detailed Description
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The secondary objectives of this study are: A. To describe, for 15 healthy volunteers with no history of venous thromboembolism (VTE), plasma nucleosome and DNA concentrations. B. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, plasma nucleosome and DNA concentrations. C. To compare plasma nucleosome and DNA concentrations between healthy volunteers and VTE patients D. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, the relationships between classification of VTE and plasma nucleosome concentrations: anatomical classification of VTE: (i)superficial, deep ((ii)distal or (iii)proximal), or (iv)pulmonary embolism circumstantial classification of VTE: (i) triggered, no chronic risk factor; (ii) untriggered, with chronic risk factor; (iii)triggered, with chronic risk factor; (iv) untriggered, no chronic risk factor (idiopathic) E. To describe, for 100 patients with a history of VTE, the variation in plasma nucleosome concentrations 6 months after the first evaluation according to the above anatomical classification according to the above circumstantial classification according to intercurrent events and treatments F. To compare the plasma concentrations of nucleosomes and free DNA G. To evaluate the relationship between plasma nucleosome and free DNA concentrations and: circulating leukocyte populations: total leukocyte count, absolute number of neutrophils, monocytes, lymphocytes markers of coagulation activation: d-dimers, circulating fibrin monomers platelet count patients on antivitamin K: INR, patients receiving heparin: antiXa activity H. Creation of a biological collection

Official Title
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Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient or volunteer must have given his/her informed and signed consent The patient or volunteer must be insured or beneficiary of a health insurance plan The patient or volunteer is available for 6 months of follow-up For group P: patient with a history of VTE For group T: healthy volunteer no history of VTE no history of chronic disease no history of neoplastic disease no history of chronic infection not taking anticoagulants, antiplatelet medications no acute disease or infection during the last 2 weeks Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patient gave birth in the past three months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with VTE<br>Group P is composed of all patients with a history of VTE. Group Px is a subgroup of 15 patients from group P. Members of Px are randomly selected from P. | |
| Healthy volunteers<br>Group T: 15 healthy volunteers with no history of VTE will be included in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma nucleosome concentration (ng/ml) | For cohortes T and P | baseline | 
| Plasma nucleosome concentration (ng/ml) | For cohortes T and P | 6 months | 
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 1 month | 
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 2 months | 
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 3 months | 
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 4 months | 
| Plasma nucleosome concentration (ng/ml) | For cohortes T and Px | 5 months | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and P | baseline | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and P | 6 months | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 1 month | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 2 months | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 3 months | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 4 months | 
| Plasma free DNA concentration (ng/ml) | For cohortes T and Px | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemogram | hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | baseline | 
| Hemogram | hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 6 months | 
| Hemogram | hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 1 month | 
| Hemogram | for cohortes T and Px: hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 2 months | 
| Hemogram | for cohortes T and Px: hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 3 months | 
| Hemogram | for cohortes T and Px: hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 4 months | 
| Hemogram | for cohortes T and Px: hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils | 5 months | 
| D-dimers (ng/ml) |  | baseline | 
| D-dimers (ng/ml) |  | 6 months | 
| D-dimers (ng/ml) | cohortes T and Px only | 1 months | 
| D-dimers (ng/ml) | cohortes T and Px only | 2 months | 
| D-dimers (ng/ml) | cohortes T and Px only | 3 months | 
| D-dimers (ng/ml) | cohortes T and Px only | 4 months | 
| D-dimers (ng/ml) | cohortes T and Px only | 5 months | 
| Fibrin monomers (ng/ml) |  | baseline | 
| Fibrin monomers (ng/ml) |  | 6 months | 
| Fibrin monomers (ng/ml) | cohortes T and Px only | 1 month | 
| Fibrin monomers (ng/ml) | cohortes T and Px only | 2 months | 
| Fibrin monomers (ng/ml) | cohortes T and Px only | 3 months | 
| Fibrin monomers (ng/ml) | cohortes T and Px only | 4 months | 
| Fibrin monomers (ng/ml) | cohortes T and Px only | 5 months | 
| creatininemia (µM/L) |  | baseline | 
| creatininemia (µM/L) |  | 6 months | 
| blood Glutamo-oxaloacetate transaminase (UI/L) |  | baseline | 
| blood Glutamo-oxaloacetate transaminase (UI/L) |  | 6 months | 
| blood glutamo-pyruvate transaminase (UI/L) |  | baseline | 
| blood glutamo-pyruvate transaminase (UI/L) |  | 6 months | 
| blood gamma-glutamyl transaminase (UI/L) |  | 6 months | 
| blood gamma-glutamyl transaminase (UI/L) |  | baseline | 
| C reactive protein (mg/l) |  | baseline | 
| C reactive protein (mg/l) |  | 6 months | 
| blood fibrinogen (g/l) |  | baseline | 
| blood fibrinogen (g/l) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma free DNA concentrations, nucleosome, plasma nucleosome concentrations, free DNA