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 : November 27, 2020
|Condition or disease||Intervention/treatment|
|Thromboembolic Venous Disease||Genetic: Genetic sample|
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|
|Official Title:||Search for New Mutations Genetic Predisposing to an Increased Risk Venous Thromboembolic Disease Idiopathic. Study "FIT GENETIQUE".|
|Actual Study Start Date :||May 27, 2010|
|Estimated Primary Completion Date :||May 27, 2021|
|Estimated Study Completion Date :||May 27, 2021|
Blood sample or saliva collection to genetic research
Genetic: Genetic sample
Blood sample or saliva collection
- 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.
- 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
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
|Contact: Francis COUTURAUD, PHDfirstname.lastname@example.org|
|Contact: Lénaïck GOURHANTemail@example.com|