Evaluating skin lesions in patients with various types of vasculitis
Official title: Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Run by University of Pennsylvania · NCT03004326 · Data updated 2026-11-12
This study is testing how skin lesions from different types of vasculitis look under a microscope to help doctors better understand and treat these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Status | Recruiting |
| Started | January 2017 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT03004326 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with active cutaneous lesions related to specific types of vasculitis such as Cryoglobulinemic vasculitis, Drug-induced vasculitis, and Eosinophilic granulomatosis with polyangiitis.
✕Probably not a fit
Patients under five years old or those at high risk for biopsy complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center observational study focuses on patients with cutaneous manifestations of different forms of vasculitis. It aims to evaluate the histopathology and transcriptome of skin lesions through punch biopsies taken from active sites. Dermatologists and primary care providers will collaborate to ensure optimal patient selection and lesion sampling. The study seeks to standardize the characterization of cutaneous vasculitis to enhance understanding and treatment approaches.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with cutaneous vasculitis.
How similar studies have gone: While this approach is observational and builds on existing knowledge, similar studies have shown promise in understanding vasculitis through histopathological evaluation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Virginia
Charlottesville, Virginia, United States Recruiting -
St. Joseph's Healthcare
Hamilton, Ontario, Canada Recruiting -
University of Toronto Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting -
University of California, Los Angeles
Los Angeles, California, United States Completed -
Boston University School of Medicine
Boston, Massachusetts, United States Completed
Show 4 more locations
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Mayo Clinic
Rochester, Minnesota, United States Completed -
Cleveland Clinic
Cleveland, Ohio, United States Completed -
Oregon Health & Science University
Portland, Oregon, United States Completed -
University of Utah
Salt Lake City, Utah, United States Completed
Study contacts
- Principal investigator: Robert Micheletti, MD — University of Pennsylvania
- Study coordinator: Carol McAlear, MA
- Email: cmcalear@upenn.edu
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I-FABP as a Predictor of Gut Involvement in Pediatric IgA Vasculitis
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.