NCT01559207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2014

Completed
Last Updated

November 17, 2025

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

March 19, 2012

Last Update Submit

November 14, 2025

Conditions

Venous Thromboembolism

Keywords

nucleosomeplasma nucleosome concentrationsfree DNAplasma free DNA concentrations

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (33)

  • Hemogram

    baseline

  • Hemogram

    6 months

  • Hemogram

    1 month

  • Hemogram

    2 months

  • Hemogram

    3 months

  • +28 more secondary outcomes

Study Arms (2)

Patients with VTE

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

Group "T": 15 healthy volunteers with no history of VTE will be included in this group.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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".

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 29883046RESULT

Biospecimen

Retention: SAMPLES WITH DNA

EDTA, CTAD and dry tubes; Biological collection at the Nîmes University Hospital.

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Sylvie Bouvier, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

April 1, 2013

Primary Completion

October 20, 2014

Study Completion

October 20, 2014

Last Updated

November 17, 2025

Record last verified: 2015-03

Locations

FR(1)