Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Recruiting

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

• Registration Number: NCT03004326
• Lead Sponsor: Peter Merkel

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-28
• Study Start: 2017-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of clinical data and linked biopsy specimens	1 year	Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.

Trial Locations

Locations (9)

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Toronto Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada