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Venous ThromboembolismNCT01559207

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

An observational study of Venous Thromboembolism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Venous Thromboembolism
How many people
120 participants
Where
1 siteFrance
Study dates
Apr 2013to 20 Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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".

Who may be able to join

  • 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":
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

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.

Read the detailed description

The secondary objectives of this study are:

  1. To describe, for 15 healthy volunteers with no history of venous thromboembolism (VTE), plasma nucleosome and DNA concentrations.
  2. To describe, for 100 patients with a history of VTE currently consulting for chronic disease or thrombophilia work-up, plasma nucleosome and DNA concentrations.
  3. To compare plasma nucleosome and DNA concentrations between healthy volunteers and VTE patients
  4. 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)
  1. 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
  1. To compare the plasma concentrations of nucleosomes and free DNA
  2. 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
  1. Creation of a biological collection
Keywords
nucleosome, plasma nucleosome concentrations, free DNA, plasma free DNA concentrations
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01559207
Study groupRoleWhat they receive
Patients with VTEGroup "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 volunteersGroup "T": 15 healthy volunteers with no history of VTE will be included in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma nucleosome concentration (ng/ml)

    For cohortes T and P

    Measured: baseline

  2. Plasma nucleosome concentration (ng/ml)

    For cohortes T and P

    Measured: 6 months

  3. Plasma nucleosome concentration (ng/ml)

    For cohortes T and Px

    Measured: 1 month

  4. Plasma nucleosome concentration (ng/ml)

    For cohortes T and Px

    Measured: 2 months

  5. Plasma nucleosome concentration (ng/ml)

    For cohortes T and Px

    Measured: 3 months

  6. Plasma nucleosome concentration (ng/ml)

    For cohortes T and Px

    Measured: 4 months

  7. Plasma nucleosome concentration (ng/ml)

    For cohortes T and Px

    Measured: 5 months

  8. Plasma free DNA concentration (ng/ml)

    For cohortes T and P

    Measured: baseline

  9. Plasma free DNA concentration (ng/ml)

    For cohortes T and P

    Measured: 6 months

  10. Plasma free DNA concentration (ng/ml)

    For cohortes T and Px

    Measured: 1 month

  11. Plasma free DNA concentration (ng/ml)

    For cohortes T and Px

    Measured: 2 months

  12. Plasma free DNA concentration (ng/ml)

    For cohortes T and Px

    Measured: 3 months

  13. Plasma free DNA concentration (ng/ml)

    For cohortes T and Px

    Measured: 4 months

  14. Plasma free DNA concentration (ng/ml)

    For cohortes T and Px

    Measured: 5 months

Secondary outcomes (33)

  1. Hemogram

    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: baseline

  2. Hemogram

    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: 6 months

  3. Hemogram

    hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: 1 month

  4. Hemogram

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: 2 months

  5. Hemogram

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: 3 months

  6. Hemogram

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: 4 months

  7. Hemogram

    for cohortes "T" and "Px": hemoglobin, platelet count, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils

    Measured: 5 months

  8. D-dimers (ng/ml)

    Measured: baseline

  9. D-dimers (ng/ml)

    Measured: 6 months

  10. D-dimers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 1 months

  11. D-dimers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 2 months

  12. D-dimers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 3 months

  13. D-dimers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 4 months

  14. D-dimers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 5 months

  15. Fibrin monomers (ng/ml)

    Measured: baseline

  16. Fibrin monomers (ng/ml)

    Measured: 6 months

  17. Fibrin monomers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 1 month

  18. Fibrin monomers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 2 months

  19. Fibrin monomers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 3 months

  20. Fibrin monomers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 4 months

  21. Fibrin monomers (ng/ml)

    cohortes "T" and "Px" only

    Measured: 5 months

  22. creatininemia (µM/L)

    Measured: baseline

  23. creatininemia (µM/L)

    Measured: 6 months

  24. blood Glutamo-oxaloacetate transaminase (UI/L)

    Measured: baseline

  25. blood Glutamo-oxaloacetate transaminase (UI/L)

    Measured: 6 months

  26. blood glutamo-pyruvate transaminase (UI/L)

    Measured: baseline

  27. blood glutamo-pyruvate transaminase (UI/L)

    Measured: 6 months

  28. blood gamma-glutamyl transaminase (UI/L)

    Measured: 6 months

  29. blood gamma-glutamyl transaminase (UI/L)

    Measured: baseline

  30. C reactive protein (mg/l)

    Measured: baseline

  31. C reactive protein (mg/l)

    Measured: 6 months

  32. blood fibrinogen (g/l)

    Measured: baseline

  33. blood fibrinogen (g/l)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2012 (estimated)
  2. Study startApr 2013
  3. Primary completion20 Oct 2014
  4. Study completion20 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01559207
Sponsor's protocol ID
LOCAL/2011/SB-02
Other IDs
2012-A00198-35
Status last verified
Mar 2015
First submitted
19 Mar 2012
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Bouvier S, Bastide S, Chouirfa S, Nouvellon E, Mercier E, Bigot L, Lavigne G, Cayla G, Perez-Martin A, Gris JC. Reliability of hemostasis biomarkers is affected by time-dependent intra-patient variability. J Thromb Haemost. 2018 Jun 8. doi: 10.1111/jth.14198. Online ahead of print.

    PubMed 29883046

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma nucleosome concentration (ng/ml) (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01559207, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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