VCRC Tissue Repository

Giant Cell Arteritis Clinical Trial

Official title:

VCRC Tissue Biorepository Collection Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967068
• Other study ID #: VCRC5511
• Secondary ID: U54AR057319
• Status: Recruiting
• Start date: November 2016
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Katie Doyle
• Email: Kathryn.Logue[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortitis
• Arteritis
• Churg-Strauss Syndrome
• Cutaneous Vasculitis
• Eosinophilic Granulomatosis With Polyangiitis
• Giant Cell Arteritis
• Granulomatosis with Polyangiitis
• Granulomatosis With Polyangiitis (Wegener's)
• Henoch-Schonlein Purpura
• IgA Vasculitis
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Polymyalgia Rheumatica
• Purpura
• Systemic Vasculitis
• Takayasu Arteritis
• Vasculitis

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	University of Toronto Mount Sinai Hospital	Toronto	Ontario
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	National Center for Advancing Translational Sciences (NCATS), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases (ORD)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify genes that increase the risk of developing vasculitis	Evaluating of clinical data and linked biopsy specimens to identify genes that increase the risk of developing vasculitis.	1 year

External Links

•   Rare Diseases Clinical Research Network
•   Vasculitis Clinical Research Consortium