Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Vasculitis Clinical Trial

— CUTIS  

Official title:

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03004326
• Other study ID #: VCRC5563
• Secondary ID: U54AR057319
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Churg-Strauss Syndrome
• Cryoglobulinemic Vasculitis (CV)
• Drug-induced Vasculitis
• Eosinophilic Granulomatosis With Polyangiitis (EGPA)
• Granulomatosis with Polyangiitis
• Granulomatosis With Polyangiitis (GPA)
• IgA Vasculitis
• Isolated Cutaneous Vasculitis
• Microscopic Polyangiitis
• Microscopic Polyangiitis (MPA)
• Polyarteritis Nodosa
• Polyarteritis Nodosa (PAN)
• Systemic Vasculitis
• Urticarial Vasculitis
• Vasculitis

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

External Links

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