Identification of New Genetic Markers of Risk of Venous Thromboembolism Recurrence by Analyzing Whole Genome

NCT ID: NCT02904967

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-18
• Study Completion Date: 2023-08-09

Brief Summary

Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a chronic disease with a recurrence rate of 30% at 10 years.

Reduce the risk of recurrence is a serious public health issue. For this it is necessary to identify patients at high risk of recurrence. However, until now, only 50% of recurrences are in the presence of known risk factors, suggesting that there are still yet unidentified risk factors.

The assumption behind this project is that there are specifically associated genetic polymorphisms to the risk of VTE recurrence.

The aim of our project is to identify these polymorphisms from genome-wide data MARTHA cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for approximately 500,000 polymorphisms.

The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be compared between cases and controls. The identification of these new genetic variants associated with VTE recurrence should allow us to improve the pathophysiological knowledge of the disease, reduce the frequency of episodes and focus research on new therapeutic approaches.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

patients with recurrent VTE

Group Type: EXPERIMENTAL

Extra Blood Draw

Intervention Type: BIOLOGICAL

patients with only one episode of VTE

Group Type: ACTIVE_COMPARATOR

Extra Blood Draw

Intervention Type: BIOLOGICAL

Interventions

Extra Blood Draw

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Caucasian topic
• Personal history of VTE confirmed by the reference diagnostic tests

Exclusion Criteria

• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle Desalbres

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2012-A01139-34

Identifier Type: OTHER

Identifier Source: secondary_id

2012-30

Identifier Type: -

Identifier Source: org_study_id