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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03004326
Other study ID # VCRC5563
Secondary ID U54AR057319
Status Recruiting
Phase
First received
Last updated
Start date January 2017
Est. completion date December 2024

Study information

Verified date January 2024
Source University of Pennsylvania
Contact Carol McAlear, MA
Email cmcalear@upenn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Canada University of Toronto Mount Sinai Hospital Toronto Ontario
United States Boston University School of Medicine Boston Massachusetts
United States University of Virginia Charlottesville Virginia
United States Cleveland Clinic Cleveland Ohio
United States University of California, Los Angeles Los Angeles California
United States University of Pennsylvania Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States University of Utah Salt Lake City Utah

Sponsors (4)

Lead Sponsor Collaborator
Peter Merkel National Center for Advancing Translational Sciences (NCATS), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Office of Rare Diseases Research (ORDR)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of clinical data and linked biopsy specimens Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology. 1 year
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