Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis

Vasculitis Clinical Trial

— FAMILYVASC  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006535
• Other study ID #: 2019-A00188-49
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 1, 2029

Study information

• Verified date: July 2019
• Source: French Vasculitis Study Group
• Contact: Benjamin Terrier, MD, PhD
• Phone: +33 1 58 41 14 61
• Email: benjamin.terrier[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Vasculitis

Intervention

Genetic:
• genetic analysis
Saliva sample collection for genetic analysis

Locations

Country	Name	City	State
France	Hôpital Cochin - Department of Internal Medicine	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Benjamin Terrier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of susceptibility loci and genes		At the moment of enrollment

External Links

•   Link