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

July 3, 2019 updated by: Benjamin Terrier

Identification of Susceptibility Loci and Genes for Systemic Vasculitis Risk, by Analyzing Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75014
        • Recruiting
        • Hôpital Cochin - Department of Internal Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of susceptibility loci and genes
Time Frame: At the moment of enrollment
At the moment of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benjamin Terrier

Investigators

  • Principal Investigator: Benjamin Terrier, MD, PhD, French Vasculitis Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2029

Study Completion (ANTICIPATED)

June 1, 2029

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00188-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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