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Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis (MARTHARecidive)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Venous Thromboembolism (VTE) | Other: vital status determination |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1183 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis: Case-control Study Nested in the MARTHA Cohort |
| Estimated Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | July 1, 2020 |
| Estimated Study Completion Date : | July 1, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
| patients with Venous thromboembolism (VTE) |
Other: vital status determination
consultation of national registries
|
- MTEV recurrence [ Time Frame: 12 months ]information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- patients of the MARTHA cohort
Exclusion Criteria:
- none
| Contact: Pierre Morange, MD | pierre.morange@ap-hm.fr |
| France | |
| Assistance Publique Hôpitaux de Marseille | |
| Marseille, France, 13005 | |
| Contact: Pierre Morange, MD pierre.morange@ap-hm.fr | |
| Study Director: | Emilie Garrido Pradalié | Assistance Publique Hôpitaux de Marseille |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 5, 2019 | ||||
| First Posted Date | June 6, 2019 | ||||
| Last Update Posted Date | June 6, 2019 | ||||
| Estimated Study Start Date | July 1, 2019 | ||||
| Estimated Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
MTEV recurrence [ Time Frame: 12 months ] information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis | ||||
| Official Title | Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis: Case-control Study Nested in the MARTHA Cohort | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 1 Day | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Venous Thromboembolism (VTE) | ||||
| Intervention | Other: vital status determination
consultation of national registries
|
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| Study Groups/Cohorts | patients with Venous thromboembolism (VTE)
Intervention: Other: vital status determination
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
1183 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 1, 2021 | ||||
| Estimated Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03977870 | ||||
| Other Study ID Numbers | 2018-27 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Assistance Publique Hopitaux De Marseille | ||||
| Study Sponsor | Assistance Publique Hopitaux De Marseille | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Assistance Publique Hopitaux De Marseille | ||||
| Verification Date | June 2019 | ||||
