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RECRUITING

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

NCT03004326•Peter Merkel

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.

Eligibility

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

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)
+2 more criteria

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

Locations (10)

University of California, Los Angeles

Los Angeles, California, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

St. Joseph's Healthcare

Hamilton, Ontario, Canada

University of Toronto Mount Sinai Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

January 1, 2017

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Cryoglobulinemic Vasculitis (CV)Drug-induced VasculitisEosinophilic Granulomatosis With Polyangiitis (EGPA)IgA VasculitisIsolated Cutaneous VasculitisGranulomatosis With Polyangiitis (GPA)Microscopic Polyangiitis (MPA)Polyarteritis Nodosa (PAN)Urticarial VasculitisVasculitis

Contacts

Carol McAlear, MA

CONTACT

cmcalear@upenn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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