Clinical trial NCT01559207: Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism
Official title: Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: nucleosome
plasma nucleosome concentrations
free DNA
plasma free DNA concentrations
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of 15 healthy volunteers with no history of VTE (group "T") and 100 patients with VTE (group "P"). Fifteen randomly selected members of group P make up the sub-group "Px".

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: baseline
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: 6 months
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: 1 month
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: 2 months
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: 3 months
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: 4 months
measure: Plasma nucleosome concentration (ng/ml)
timeFrame: 5 months
measure: Plasma free DNA concentration (ng/ml)
timeFrame: baseline
measure: Plasma free DNA concentration (ng/ml)
timeFrame: 6 months
measure: Plasma free DNA concentration (ng/ml)
timeFrame: 1 month
measure: Plasma free DNA concentration (ng/ml)
timeFrame: 2 months
measure: Plasma free DNA concentration (ng/ml)
timeFrame: 3 months
measure: Plasma free DNA concentration (ng/ml)
timeFrame: 4 months
measure: Plasma free DNA concentration (ng/ml)
timeFrame: 5 months
Secondary outcomes:
measure: Hemogram
timeFrame: baseline
measure: Hemogram
timeFrame: 6 months
measure: Hemogram
timeFrame: 1 month
measure: Hemogram
timeFrame: 2 months
measure: Hemogram
timeFrame: 3 months
measure: Hemogram
timeFrame: 4 months
measure: Hemogram
timeFrame: 5 months
measure: D-dimers (ng/ml)
timeFrame: baseline
measure: D-dimers (ng/ml)
timeFrame: 6 months
measure: D-dimers (ng/ml)
timeFrame: 1 months
measure: D-dimers (ng/ml)
timeFrame: 2 months
measure: D-dimers (ng/ml)
timeFrame: 3 months
measure: D-dimers (ng/ml)
timeFrame: 4 months
measure: D-dimers (ng/ml)
timeFrame: 5 months
measure: Fibrin monomers (ng/ml)
timeFrame: baseline
measure: Fibrin monomers (ng/ml)
timeFrame: 6 months
measure: Fibrin monomers (ng/ml)
timeFrame: 1 month
measure: Fibrin monomers (ng/ml)
timeFrame: 2 months
measure: Fibrin monomers (ng/ml)
timeFrame: 3 months
measure: Fibrin monomers (ng/ml)
timeFrame: 4 months
measure: Fibrin monomers (ng/ml)
timeFrame: 5 months
measure: creatininemia (µM/L)
timeFrame: baseline
measure: creatininemia (µM/L)
timeFrame: 6 months
measure: blood Glutamo-oxaloacetate transaminase (UI/L)
timeFrame: baseline
measure: blood Glutamo-oxaloacetate transaminase (UI/L)
timeFrame: 6 months
measure: blood glutamo-pyruvate transaminase (UI/L)
timeFrame: baseline
measure: blood glutamo-pyruvate transaminase (UI/L)
timeFrame: 6 months
measure: blood gamma-glutamyl transaminase (UI/L)
timeFrame: 6 months
measure: blood gamma-glutamyl transaminase (UI/L)
timeFrame: baseline
measure: C reactive protein (mg/l)
timeFrame: baseline
measure: C reactive protein (mg/l)
timeFrame: 6 months
measure: blood fibrinogen (g/l)
timeFrame: baseline
measure: blood fibrinogen (g/l)
timeFrame: 6 months
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Sylvie Bouvier, MD
role: PRINCIPAL_INVESTIGATOR
References: