VCRC Tissue Repository
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Aortitis, Cutaneous Vasculitis, Eosinophilic Granulomatosis With Polyangiitis, Giant Cell Arteritis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
VCRC Tissue Biorepository Collection Protocol
Overview
The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.
Detailed description
Biopsy specimens collected as standard of care for these diseases will be retrieved and used in research. The most common biopsies performed are kidney, lung, skin, nerves, and vessels; however, other tissue is also of interest for the study. Biopsies are not performed as part of this protocol, rather we will request consent to collect biopsy specimens already collected under routine care.
Primary outcome measures
- Identify genes that increase the risk of developing vasculitis [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- A participant will be deemed eligible for this study if the participant is/was enrolled in another one of the VCRC observational/longitudinal protocols (5502, 5503, 5504, 5505, 5506, 5507, 5563) and/or one of the VCRC interventional studies (5522, 5523, 5526, 5527, or 5562).
Exclusion criteria
- Inability to give informed consent (or their guardians in the case of children) and to sign the consent form.
- Unwilling to allow the use of their tissue for research.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 6 centers
- Brigham and Women's Hospital — Boston
- Boston University School of Medicine — Boston
- Cleveland Clinic — Cleveland
- University of Pennsylvania — Philadelphia
- University of Pittsburgh — Pittsburgh
- University of Utah — Salt Lake City
Canada · 2 centers
- St. Joseph's Healthcare — Hamilton
- University of Toronto Mount Sinai Hospital — Toronto
Identifiers
NCT: NCT02967068 · VCRC5511 · U54AR057319