Observational Study of Vasculitis

This is an observational study called CUTIS, looking at different types of vasculitis (inflammation of blood vessels). Researchers want to understand more about how Cryoglobulinemic Vasculitis, Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), IgA Vasculitis, and Isolated Cutaneous Vasculitis affect the skin. They will study skin samples and medical information from people with these conditions. The goal is to learn more about these diseases by looking at clinical data and skin biopsy samples over one year. You may be able to join if you are 5 years or older, have a skin lesion thought to be from active vasculitis, and have a suspected or confirmed diagnosis of one of the listed vasculitis types. The study status is currently unclear.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include 50 participants.
What's involved
You would have a punch skin biopsy taken from an active vasculitis lesion. Your clinical data will also be evaluated.
Compensation
Not stated in the trial record.
Follow-up
Your clinical data and biopsy specimens will be evaluated for one year.

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NCT03004326

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Recruiting
Not specifiedAges 5+Observational
Peter Merkel
~50 participants
Updated 2026-01-22 on ClinicalTrials.gov

At a glance

Recruiting sites
4 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of clinical data and linked biopsy specimens
Measured over 1 year
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
10 sites across 9 states
Ontario2
California1
Massachusetts1
Minnesota1
Ohio1
Oregon1
Pennsylvania1
Utah1
  • Robert Micheletti, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Peter Grayson, MD, MSc · PRINCIPAL_INVESTIGATOR · The National Institute of Arthritis and Musculoskeletal and Skin Diseases

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Eligibility criteria

Inclusion

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

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
  • Evaluation of clinical data and linked biopsy specimens1 year

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