Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), Granulomatosis With Polyangiitis (GPA), IgA Vasculitis, Isolated Cutaneous Vasculitis, Microscopic Polyangiitis (MPA), Polyarteritis Nodosa (PAN), Urticarial Vasculitis, Vasculitis
Conditions
Keywords
DIV, CSS, EGPA, HSP, GPA, MPA, PAN, Wegeners
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.
Interventions
None listed
Sponsors
Peter Merkel
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Sciences (NCATS)
Office of Rare Diseases Research (ORDR)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical data and linked biopsy specimens | 1 year | Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology. |
Countries
Canada, United States
Contacts
CONTACTCarol McAlear, MA
PRINCIPAL_INVESTIGATORRobert Micheletti, MD
University of Pennsylvania
PRINCIPAL_INVESTIGATORPeter Grayson, MD, MSc
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
Outcome results
None listed