- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04006535
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
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
- Name: Benjamin Terrier, MD, PhD
- Phone Number: +33 1 58 41 14 61
- Email: benjamin.terrier@aphp.fr
Study Contact Backup
- Name: Hicham Kardaoui, MSc
- Phone Number: +33 1 58 41 16 46
- Email: hicham.kardaoui@aphp.fr
Study Locations
-
-
Ile De France
-
Paris, Ile De France, France, 75014
- Recruiting
- Hôpital Cochin - Department of Internal Medicine
-
Contact:
- Benjamin Terrier, MD, PhD
- Phone Number: + 01 58 41 14 61
- Email: benjamin.terrier@aphp.fr
-
-
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
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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