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NCT Number: NCT03004326

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

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

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Key information

Conditions

Cryoglobulinemic Vasculitis (CV) Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Arteritis Autoimmune Diseases Blood Coagulation Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Churg-Strauss Syndrome Cryoglobulinemia, Familial Mixed Drug-induced Vasculitis Eosinophilic Granulomatosis With Polyangiitis (EGPA) Granuloma Granulomatosis With Polyangiitis (GPA) Granulomatosis with Polyangiitis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Isolated Cutaneous Vasculitis Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Microscopic Polyangiitis Microscopic Polyangiitis (MPA) Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Polyarteritis Nodosa Polyarteritis Nodosa (PAN) Purpura Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Systemic Vasculitis Urticarial Vasculitis Vascular Diseases Vasculitis

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Healthcare, Hamilton, Ontario, Canada

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About this study

This study employs a multi-center approach to evaluate cutaneous vasculitis across several forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be evaluated by teams of primary vasculitis care providers and Dermatologists in order to facilitate optimal selection of patients and sampling of lesions.

A punch skin biopsy at a site of active vasculitis will be the source of material for histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis will be characterized using a standardized approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Evaluation of clinical data and linked biopsy specimens

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carol McAlear, MA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peter Merkel

Other

Collaborators

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

Registry information

Acronym: CUTIS

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Dec 28, 2016
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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