Actively Recruiting
Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Led by Peter Merkel · Updated on 2026-01-22
50
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Peter Merkel
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit
Participants with cutaneous vasculitis undergo a punch skin biopsy and clinical evaluation to characterize the histopathology and transcriptomics of their lesions.
1 visit (in-person)
Duration - 1 year
Participants are followed for clinical data and biopsy specimen evaluation over 1 year.
Follow-up visits as per clinical care
Trial Site Locations
Total: 10 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Completed
2
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Completed
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Completed
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Completed
5
Oregon Health & Science University
Portland, Oregon, United States
Completed
6
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
University of Utah
Salt Lake City, Utah, United States
Completed
8
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
9
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Actively Recruiting
10
University of Toronto Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
Research Team
C
Carol McAlear, MA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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