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New Genetic Mutations in Thromboembolic Venous Disease Idiopathic. Study "FIT GENETIQUE". (Fit-Génétique)

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ClinicalTrials.gov Identifier: NCT02841085
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or identifying genes involved in subjects at high risk for thrombotic and in whom screening for detectable hereditary thrombophilia was negative.

Condition or disease Intervention/treatment
Thromboembolic Venous Disease Genetic: Genetic sample

Detailed Description:

Venous thromboembolism desease is a public health problem justifying major primary and secondary prevention policy. When VTE occurs in the absence of risk factor clinically identifiable ( "idiopathic"), an inherited biological risk factor ( "inherited thrombophilia") is found in 30% of cases. However, in patients with idiopathic VTE, the risk of recurrent venous thromboembolism is very high, whether detectable inherited thrombophilia was found or not.

This first observation suggests that patients with idiopathic VTE and no detectable thrombophilia are likely to have an underlying unknown thrombophilia that are yet to be discovered.

This hypothesis is further supported by the results of the study "FIT" (Regional PHRC 2001, promoter CHU Brest, Investigator Main: Francis Couturaud, EA3878 Brest, France, and investigator Associate: Clive Kearon, McMaster University, Hamilton, Ontario, Canada), a cross international study evaluating the risk of VTE among the family members first degree of patients a first idiopathic VTE episode. In this large study cross-1950 family members first degree (topics study) of 372 patients with a first episode of VTE Idiopathic (propositi) were included (50% included in Brest and 50% inclusive in Canada). The main result is that the risk of VTE among family members first degree is high and similar, the proband either bearer or without a detectable hereditary thrombophilia. In other words, even in the absence of detectable hereditary thrombophilia, the risk of VTE among family members first degree is high. This study has identified the subjects in that it is likely they have an inherited thrombophilia which has not yet been discovered.


Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Search for New Mutations Genetic Predisposing to an Increased Risk Venous Thromboembolic Disease Idiopathic. Study "FIT GENETIQUE".
Study Start Date : May 27, 2010
Estimated Primary Completion Date : May 27, 2019
Estimated Study Completion Date : May 27, 2019

Group/Cohort Intervention/treatment
Genetic sample
Blood sample or saliva collection to genetic research
Genetic: Genetic sample
Blood sample or saliva collection




Primary Outcome Measures :
  1. Research of new genetic mutations [ Time Frame: 1 day ]

    Identify new genetic mutations predisposing risk increased Thromboembolic Venous Disease by locating and / or identifying the genes involved in subjects at high risk for thrombotic and in whom screening for detectable inherited or acquired thrombophilia was negative.

    was negative.



Secondary Outcome Measures :
  1. Quantify the presence of new thrombophilia hereditary risk of Thromboembolic Venous Disease [ Time Frame: 1 day ]
    Quantify the importance of the presence of new thrombophilia hereditary risk of Thromboembolic Venous Disease.


Biospecimen Retention:   Samples With DNA
Blood or saliva sample


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:

  1. / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ;
  2. / were included in the "FIT" study;
  3. / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
Criteria

Inclusion Criteria:

  • Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:

    1. / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ;
    2. / were included in the "FIT" study;
    3. / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
  • Written Consent of propositi and their members in the 2nd, 3rd and 4th respective degree to participate in this study.

Exclusion Criteria:

  • Presence of detectable thrombophilia in the propositi.
  • Presence of hereditary thrombophilia or detectable gained at family members.
  • No information may be obtained on previous venous thromboembolism among family members on 1 degree
  • Everything about the study (depending on the population and members of proband Family 1st, 2nd, 3rd and 4th degree) less than 15 years.
  • The family member is an adopted child

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841085


Contacts
Contact: Francis COUTURAUD, PHD francis.couturaud@chu-brest.fr
Contact: Lénaïck GOURHANT lenaick.gourhant@chu-brest.fr

Locations
France
CHRU de Brest Recruiting
Brest, France, 29200
Contact: Francis Couturaud, PHD       francis.couturaud@chu-brest.fr   
Contact: Lénaïck Gourhant       lenaick.gourhant@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02841085     History of Changes
Other Study ID Numbers: RB 09.058 Fit Génétique
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by University Hospital, Brest:
Genetic
Thrombophilia