Clinical trial NCT02967068: VCRC Tissue Repository
Official title: VCRC Tissue Biorepository Collection Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortitis
Cutaneous Vasculitis
Eosinophilic Granulomatosis with Polyangiitis
Giant Cell Arteritis
Granulomatosis with Polyangiitis (Wegener's)
Henoch-Schonlein Purpura
IgA Vasculitis
Microscopic Polyangiitis
Polyarteritis Nodosa
Takayasu Arteritis
Churg-Strauss Syndrome
Keywords: CSS
EGPA
GCA
GPA
MPA
PAN
TAK
HSP
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Center for Advancing Translational Sciences (NCATS)
name: Office of Rare Diseases (ORD)
First posted: 2016-11-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1000 patients with GCA, TAK, PAN, GPA, MPA, EGPA, cutaneous vasculitis and aortitis will potentially be enrolled into the VCRC Tissue Biorepository Collection Protocol.

The protocol will be conducted at the major vasculitis centers in the United States and Canada participating in selected VCRC studies. Biopsy specimens collected as standard of care for these diseases will be retrieved and used in research.

Biopsies are not performed as part of this protocol, rather we will request consent to collect biopsy specimens already collected under routine care.

Brief 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.

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.

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.

Primary outcomes:
measure: Identify genes that increase the risk of developing vasculitis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Pennsylvania
name: Peter A Merkel, MD, MPH
role: STUDY_CHAIR
References: