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RecruitingNCT03004326CUTISUpdated Jan 22, 2026

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

An observational study in Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis and Eosinophilic Granulomatosis With Polyangiitis (EGPA), sponsored by Peter Merkel. Recruiting at 10 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Peter Merkel · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
5 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Evaluation of clinical data and linked biopsy specimens

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

    Time frame: 1 year

06

Study locations

4 of 10 sites recruiting
  • 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
07

References and documents

Related links

08

Registry details

Key details

Study ID
NCT03004326
Lead sponsor
Peter Merkel
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), Office of Rare Diseases Research (ORDR)
Responsible party
Peter Merkel (Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania) — Sponsor-investigator
First posted
Dec 28, 2016
Start date
Jan 2017
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 22, 2026

Study contacts

Carol McAlear, MA
Contact
cmcalear@upenn.edu
Robert Micheletti, MD
principal investigator · University of Pennsylvania
Peter Grayson, MD, MSc
principal investigator · The National Institute of Arthritis and Musculoskeletal and Skin Diseases

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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