Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Peter Merkel

Status: Enrolling

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03004326

VCRC5563

U54AR057319 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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