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Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC)

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ClinicalTrials.gov Identifier: NCT04006535
Recruitment Status : Recruiting
First Posted : July 3, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Terrier, French Vasculitis Study Group

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

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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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Genetic: genetic analysis
    Saliva sample collection for genetic analysis


Primary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion criteria for subjects with vasculitis

  • Children and adults
  • Patients with vasculitis, as defined in the Chapel Hill International Classification in its revised version of 2012
  • Patient information and signed informed consent
  • Pregnant and breastfeeding women can be included in the study

Inclusion criteria for healthy subjects

  • Children and adults
  • Do not have vasculitis, as defined in the Chapel Hill International Classification in its revised version of 2012, or relatives on the 1st; 2nd; 3rd or 4th degree of a patient with vasculitis
  • Patient information and signed informed consent
  • Pregnant and breastfeeding women can be included in the study

Exclusion criteria:

  • Refusal of consent or inability to obtain consent
  • Dementia or unauthorized patient, for psychiatric or intellectual failure reasons, to receive information about the protocol and to give informed consent.
  • Uncooperative patient, or any pathology that could make the patient potentially non-compliant to the study procedures, and patients interned for regulatory or legal reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006535


Contacts
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Contact: Benjamin Terrier, MD, PhD +33 1 58 41 14 61 benjamin.terrier@aphp.fr
Contact: Hicham Kardaoui, MSc +33 1 58 41 16 46 hicham.kardaoui@aphp.fr

Locations
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France
Hôpital Cochin - Department of Internal Medicine Recruiting
Paris, Ile De France, France, 75014
Contact: Benjamin Terrier, MD, PhD    + 01 58 41 14 61    benjamin.terrier@aphp.fr   
Sponsors and Collaborators
Benjamin Terrier
Investigators
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Principal Investigator: Benjamin Terrier, MD, PhD French Vasculitis Study Group

Additional Information:
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Responsible Party: Benjamin Terrier, Professor, French Vasculitis Study Group
ClinicalTrials.gov Identifier: NCT04006535     History of Changes
Other Study ID Numbers: 2019-A00188-49
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Terrier, French Vasculitis Study Group:
Vasculitis
Additional relevant MeSH terms:
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Vasculitis
Vascular Diseases
Cardiovascular Diseases