Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

NCT03004326 | Recruiting DMC

• 2 other identifiers: VCRC5563U54AR057319
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 10

Brief Summary

Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.

Conditions

Cryoglobulinemic Vasculitis (CV); Drug-induced Vasculitis; Eosinophilic Granulomatosis With Polyangiitis (EGPA); IgA Vasculitis; Isolated Cutaneous Vasculitis; Granulomatosis With Polyangiitis (GPA); Microscopic Polyangiitis (MPA); Polyarteritis Nodosa (PAN); Urticarial Vasculitis; Vasculitis

Keywords

DIV; CSS; EGPA; HSP; GPA; MPA; PAN; Wegeners

Outcome Measures

Primary Outcomes (1)

• Evaluation of clinical data and linked biopsy specimens

  Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.

  1 year

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

About 56 people with vasculitis will take part in this study at approximately 20 medical centers across North America. Patients with CV, DiV, EGPA, IgA vasculitis, GPA, MPA, PAN, isolated cutaneous vasculitis and urticarial vasculitis will potentially be enrolled into this study. The protocol will be conducted at the major vasculitis centers in the United States and Canada participating in selected VCRC studies. Skin biopsy specimens collected as standard of care for these diseases will be retrieved and used in research.

You may qualify if:

• Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis
• Have a suspected or confirmed diagnosis of:
• Cryoglobulinemic vasculitis (CV)
• Drug-induced vasculitis
• Eosinophilic granulomatosis with polyangiitis (EGPA)
• IgA vasculitis
• Isolated cutaneous vasculitis
• Granulomatosis with polyangiitis (GPA)
• Microscopic polyangiitis (MPA)
• Polyarteritis nodosa (PAN)
• Urticarial vasculitis
• Be willing and able to provide written informed consent (or assent for those under

You may not qualify if:

• You are less than five years old
• Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy
• You have a neutrophil count (type of white blood cell) less than 1500/mm3, platelet count less than 50,000/mm3, or a hemoglobin less than 7 g/dL
• You have an uncontrolled disease that could prevent you from completing the study procedures
• You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study
• You are pregnant or nursing
• You are not able to provide informed consent

Sponsors & Collaborators

• Peter Merkel: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Office of Rare Diseases Research (ORDR): collaborator

Study Sites (10)

University of California, Los Angeles

Los Angeles, California, 90095, United States

COMPLETED

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

COMPLETED

Mayo Clinic

Rochester, Minnesota, 55905, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

COMPLETED

Oregon Health & Science University

Portland, Oregon, United States

COMPLETED

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Utah

Salt Lake City, Utah, United States

COMPLETED

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

St. Joseph's Healthcare

Hamilton, Ontario, Canada

RECRUITING

University of Toronto Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected solely for research purposes. The reason we are performing these laboratory-based research studies is to help us better understand whether abnormalities detected in a subjects skin biopsy can also be detected in their blood.

MeSH Terms

Conditions

Cryoglobulinemia, Familial Mixed; Churg-Strauss Syndrome; IgA Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Polyarteritis Nodosa; Vasculitis

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System 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; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteritis

Study Officials

• Robert Micheletti, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Peter Grayson, MD, MSc

  The National Institute of Arthritis and Musculoskeletal and Skin Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol McAlear, MA

CONTACT

cmcalear@upenn.edu

Study Design

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

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 28, 2016
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CA (2); US (8)