New Genetic Mutations in Thromboembolic Venous Disease Idiopathic. Study "FIT GENETIQUE".

NCT02841085 | Completed DMC

• 1 other identifier: RB 09.058 Fit Génétique
• Study Type: observational
• Target: 613
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolic Venous Disease

Keywords

Genetic; Thrombophilia

Outcome Measures

Primary Outcomes (1)

• Research of new genetic mutations

  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 Outcomes (1)

• Quantify the presence of new thrombophilia hereditary risk of Thromboembolic Venous Disease

  1 day

Study Arms (1)

Genetic sample

Blood sample or saliva collection to genetic research

Genetic: Genetic sample

Interventions

Genetic sample GENETIC

Blood sample or saliva collection

Genetic sample

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29200, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood or saliva sample

MeSH Terms

Conditions

Thrombophilia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 22, 2016
• Study Start: May 27, 2010
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

FR (1)