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出境医 / 临床实验 / Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC)
Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC)
Study Description
Brief Summary:
The FAMILYVASC study is a prospective observational study which will aim to identify susceptibility loci and genes for systemic vasculitis risk in patients with familial or pediatric forms of vasculitis. Genetic analysis based on whole exome sequencing will be carried out through salivary DNA.
| Condition or disease | Intervention/treatment |
|---|---|
| Vasculitis | Genetic: genetic analysis |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Family-Based |
| Time Perspective: | Prospective |
| Official Title: | Identification of Susceptibility Loci and Genes for Systemic Vasculitis Risk, by Analyzing Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC Study) |
| Actual Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | June 1, 2029 |
| Estimated Study Completion Date : | June 1, 2029 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Identification of susceptibility loci and genes [ Time Frame: At the moment of enrollment ]
Biospecimen Retention: Samples With DNA
Saliva samples will be collected for genetic analysis and identification of susceptibility loci and genes for the risk of vasculitis.
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 1, 2019 | ||||||||
| First Posted Date | July 5, 2019 | ||||||||
| Last Update Posted Date | July 8, 2019 | ||||||||
| Actual Study Start Date | June 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 1, 2029 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Identification of susceptibility loci and genes [ Time Frame: At the moment of enrollment ] | ||||||||
| Original Primary Outcome Measures |
Identification of susceptibility loci and genes [ Time Frame: At the moment of enrollement ] | ||||||||
| Change History | |||||||||
| 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 | Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis | ||||||||
| Official Title | Identification of Susceptibility Loci and Genes for Systemic Vasculitis Risk, by Analyzing Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC Study) | ||||||||
| Brief Summary | The FAMILYVASC study is a prospective observational study which will aim to identify susceptibility loci and genes for systemic vasculitis risk in patients with familial or pediatric forms of vasculitis. Genetic analysis based on whole exome sequencing will be carried out through salivary DNA. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Family-Based Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Saliva samples will be collected for genetic analysis and identification of susceptibility loci and genes for the risk of vasculitis.
|
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Adult and childhood patients (no age limit) with familial and pediatric forms of vasculitis as defined in Chapel Hill's international nomenclature in its revised 2012 version. | ||||||||
| Condition | Vasculitis | ||||||||
| Intervention | Genetic: genetic analysis
Saliva sample collection for genetic analysis
|
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment |
100 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 1, 2029 | ||||||||
| Estimated Primary Completion Date | June 1, 2029 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion criteria for subjects with vasculitis
Inclusion criteria for healthy subjects
Exclusion criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04006535 | ||||||||
| Other Study ID Numbers | 2019-A00188-49 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Benjamin Terrier, French Vasculitis Study Group | ||||||||
| Study Sponsor | Benjamin Terrier | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | French Vasculitis Study Group | ||||||||
| Verification Date | July 2019 | ||||||||
