Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

NCT ID: NCT03004326

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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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 Vasculitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Office of Rare Diseases Research (ORDR)

UNKNOWN

Sponsor Role collaborator

Peter Merkel

OTHER

Sponsor Role lead

Responsible Party

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Peter Merkel

Chief, Division of Rheumatology Professor of Medicine and Epidemiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert Micheletti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Peter Grayson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The National Institute of Arthritis and Musculoskeletal and Skin Diseases

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status COMPLETED

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status COMPLETED

Mayo Clinic

Rochester, Minnesota, United States

Site Status COMPLETED

Cleveland Clinic

Cleveland, Ohio, United States

Site Status COMPLETED

Oregon Health & Science University

Portland, Oregon, United States

Site Status COMPLETED

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status COMPLETED

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Site Status RECRUITING

University of Toronto Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Carol McAlear, MA

Role: CONTACT

Facility Contacts

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Laura Cesar

Role: primary

Lauren Kuhns

Role: primary

Sandra Messier

Role: primary

Nazrana Haq

Role: primary

Related Links

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Other Identifiers

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U54AR057319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VCRC5563

Identifier Type: -

Identifier Source: org_study_id

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