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NCT02967068 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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Terminated NCT02531633 - Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis Phase 3
Completed NCT03409913 - Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA N/A
Completed NCT03765424 - Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
Completed NCT01910038 - Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. Phase 2
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