Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis

NCT03977870 | Completed

• 1 other identifier: 2018-27
• Study Type: observational
• Target: 843
• Locations: 1 country
• Sites: 1

Brief Summary

Venous thromboembolism (VTE) is a common and potentially fatal pathology in France. The risk of recurrence is around 5 to 7% per year. The identification of patients at risk of VTE and its prevention is a real health issue in particular. 50% of MTEV recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for MTEV recurrence that have not been identified to date. In the last ten years, so-called "genome-whole" or "genome wide" association (GWAS) approaches have identified new genetic risk factors for the first episode of VTE. On the other hand, no study has focused on the predictive factors of recurrence. The previous project, conducted from 2012 (NCT02904967), had as its main objective to identify new genes for susceptibility to MTEV recurrence by comparing cases of MTEV recurrence versus controls having had a single episode of MTEV. The MARTHA cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of VTE. Follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of VTE. The objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. . These new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of MTEV.

Conditions

Venous Thromboembolism (VTE)

Outcome Measures

Primary Outcomes (1)

• MTEV recurrence

  information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death.

  12 months

Study Arms (1)

patients with Venous thromboembolism (VTE)

Other: vital status determination

Interventions

vital status determination OTHER

consultation of national registries

patients with Venous thromboembolism (VTE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Martha cohort is composed of 1542 subjects from the Region of Marseille with at least one episode of VTE documented. Patients in the MARTHA cohort have already all been genotyped for approximately 500,000 polymorphisms

You may qualify if:

• patients of the MARTHA cohort

You may not qualify if:

• none

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emilie Garrido Pradalié

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: July 1, 2018
• Primary Completion: May 13, 2019
• Study Completion: August 3, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

FR (1)