- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841085
New Genetic Mutations in Thromboembolic Venous Disease Idiopathic. Study "FIT GENETIQUE". (Fit-Génétique)
Search for New Mutations Genetic Predisposing to an Increased Risk Venous Thromboembolic Disease Idiopathic. Study "FIT GENETIQUE".
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brest, France, 29200
- CHRU de Brest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:
- / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ;
- / were included in the "FIT" study;
- / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
Description
Inclusion Criteria:
Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:
- / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ;
- / were included in the "FIT" study;
- / 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Genetic sample
Blood sample or saliva collection to genetic research
|
Blood sample or saliva collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RB 09.058 Fit Génétique
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thromboembolic Venous Disease
-
Direction Centrale du Service de Santé des ArméesRecruitingVenous Thromboembolic DiseaseFrance
-
Qianfoshan HospitalNot yet recruitingVenous Thromboembolic DiseaseChina
-
University Hospital, Strasbourg, FranceRecruitingVenous Thromboembolic DiseaseFrance
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
University of California, Los AngelesCompletedPulmonary Embolism | Deep Venous Thrombosis | Venous Thromboembolic Disease | Right Heart Pathology
-
Fundación Pública Andaluza para la gestión de la...RecruitingPulmonary Disease | Pulmonary Embolism | Deep Venous Thrombosis | Respiratory Disease | Venous Thromboembolic Disease | Screening | UndefinedSpain
-
Odense University HospitalCompletedVenous Thromboembolic DiseaseDenmark
-
University Hospital, BrestNot yet recruitingThromboembolic Venous DiseaseFrance
-
China-Japan Friendship HospitalNot yet recruitingPulmonary Embolism | Deep Venous Thrombosis | Venous Thromboembolic Disease
-
University Hospital, Strasbourg, FranceUnknownVenous Thromboembolic DiseaseFrance
Clinical Trials on Genetic sample
-
University Hospital, Strasbourg, FranceCompletedBacteremia | Endocarditis | Staphylococcus Lugdunensis | Virulence FactorsFrance
-
University of Southern CaliforniaNational Cancer Institute (NCI)Recruiting
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science UniversityRecruitingMalignant Solid Neoplasm | Lynch Syndrome | Hematopoietic and Lymphoid System Neoplasm | Breast Ductal Carcinoma In Situ | Hereditary Neoplastic Syndrome | BRCA1/2-Associated Hereditary Breast and Ovarian Cancer SyndromeUnited States
-
Assistance Publique - Hôpitaux de ParisUnknownBipolar Disorder | Euthymic StateFrance
-
University Hospital, Clermont-FerrandHeart and Research Foundation; French Coronary Atheroma and Interventional...CompletedSpontaneous Coronary Artery Dissection | Spontaneous Coronary Artery HaematomaFrance
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Breast Carcinoma | Digestive System Carcinoma | Head and Neck Carcinoma | Skin Carcinoma | Malignant Female Reproductive System Neoplasm | Malignant Brain Neoplasm | Carcinoma of Unknown Primary | Central Nervous System Carcinoma | Genitourinary System Carcinoma | Malignant Musculoskeletal...United States
-
The Guthrie ClinicActive, not recruiting
-
University Hospital, MontpellierInstitut National de la Santé Et de la Recherche Médicale, France; Sys2Diag...Completed
-
University of UtahEnrolling by invitationTotal Joint Arthroplasty | Periprosthetic Joint InfectionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)Enrolling by invitationProstate CarcinomaUnited States