Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), IgA Vasculitis. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Evaluation of clinical data and linked biopsy specimens [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- University of California, Los Angeles — Los Angeles
- Boston University School of Medicine — Boston
- Mayo Clinic — Rochester
- Cleveland Clinic — Cleveland
- Oregon Health & Science University — Portland
- University of Pennsylvania — Philadelphia
- University of Utah — Salt Lake City
- University of Virginia — Charlottesville
Canada · 2 centers
- St. Joseph's Healthcare — Hamilton
- University of Toronto Mount Sinai Hospital — Toronto
Identifiers
NCT: NCT03004326 · VCRC5563 · U54AR057319