VCRC Tissue Repository

NCT02967068 | Recruiting DMC

• 2 other identifiers: VCRC5511U54AR057319
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• Office of Rare Diseases (ORD): collaborator

Study Sites (8)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

COMPLETED

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

COMPLETED

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

COMPLETED

University of Utah

Salt Lake City, Utah, 84132, United States

COMPLETED

St. Joseph's Healthcare

Hamilton, Ontario, L8N 3B6, Canada

RECRUITING

University of Toronto Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Links

• Vasculitis Clinical Research Consortium
• Rare Diseases Clinical Research Network

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Aortitis; Skin Diseases, Vascular; Churg-Strauss Syndrome; Giant Cell Arteritis; Granulomatosis with Polyangiitis; IgA Vasculitis; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Skin Diseases; Skin and Connective Tissue Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Arteritis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Immune Complex Diseases; Hypersensitivity; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Cerebral Small Vessel Diseases; Aortic Arch Syndromes

Study Officials

• Peter A Merkel, MD, MPH

  University of Pennsylvania

  STUDY CHAIR

Central Study Contacts

Katie Doyle

CONTACT

Kathryn.Logue@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Rheumatology Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (2)