Identification of New Genetic Markers of Risk of Venous Thromboembolism Recurrence by Analyzing Whole Genome
2 other identifiers
interventional
221
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2016
CompletedFirst Submitted
Initial submission to the registry
September 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2023
CompletedAugust 14, 2023
August 1, 2023
3.5 years
September 8, 2016
August 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
allelic frequency of 500,000 already genotyped polymorphisms
36 months
Study Arms (2)
patients with recurrent VTE
EXPERIMENTALpatients with only one episode of VTE
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Caucasian topic
- Personal history of VTE confirmed by the reference diagnostic tests
You may not qualify if:
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13005, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urielle Desalbres
Assistance Publique Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 19, 2016
Study Start
January 18, 2013
Primary Completion
July 18, 2016
Study Completion
August 9, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share