What is this study trying to find out about vasculitis?

This study is evaluating the skin tissue changes and gene activity in different types of cutaneous vasculitis. Researchers want to better understand the disease by examining skin lesions from patients with vasculitis. The study is led by Peter Merkel and involves multiple medical centers.

Who may be eligible for this vasculitis clinical trial?

Patients aged 5 years and older with suspected or confirmed types of vasculitis affecting the skin may be eligible. Both males and females can participate. Key factors include having active vasculitis skin lesions and being able to consent. Please review eligibility criteria for more details.

Is there any cost to participate in this vasculitis clinical trial?

Study-related care, including the biopsy procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 5Years +

All Genders

ID03004326

Study of Skin Biopsy and Gene Analysis in Various Types of Systemic Vasculitis

Led by Peter Merkel · Updated on 2026-01-22

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to better understand cutaneous vasculitis by studying skin lesions in patients with various types of idiopathic vasculitis. It involves a multi-center approach with both primary vasculitis care providers and dermatologists working together to select suitable patients and collect lesion samples for analysis. The study focuses on evaluating the histopathology and gene expression profiles transcriptome of these skin lesions. Participants with active vasculitis skin lesions will undergo a punch biopsy to collect tissue samples. These samples will be examined using standardized methods to assess the histopathology and transcriptomic characteristics of the cutaneous vasculitis. The study does not involve any experimental treatments but gathers detailed clinical data and biopsy specimens for analysis. Participants will be evaluated by specialists, who will collect clinical information and perform skin biopsies at affected sites. The study will review clinical data linked to biopsy samples over one year. Researchers will monitor the samples to better characterize the disease at the tissue level. The total participation time varies, with follow-up focused on the evaluation of biopsy results and clinical data.

CONDITIONS

Brief Title

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Who Can Participate

Age: 5Years +

All Genders

Eligibility Criteria

You may qualify if you...

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), or urticarial vasculitis
Be willing and able to provide written informed consent (or assent for those under 18)

You will not qualify if you...

Younger than five years old
Not a candidate for biopsy or at high risk of infection, bleeding, or other biopsy-related complications as judged by a doctor
Neutrophil count less than 1500/mm3, platelet count less than 50,000/mm3, or hemoglobin less than 7 g/dL
Have uncontrolled disease that would prevent completing study procedures
Active infection at or near the biopsy site, poor circulation, or presence of bony prominence increasing risk for complications
Pregnant or nursing
Unable to provide informed consent

Research Team

Carol McAlear, MA

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