Clinical trial NCT03004326: Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Official title: Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: DIV
CSS
EGPA
HSP
GPA
MPA
PAN
Wegeners
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Center for Advancing Translational Sciences (NCATS)
name: Office of Rare Diseases Research (ORDR)
First posted: 2016-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 56 people with vasculitis will take part in this study at approximately 20 medical centers across North America. Patients with CV, DiV, EGPA, IgA vasculitis, GPA, MPA, PAN, isolated cutaneous vasculitis and urticarial vasculitis will potentially be enrolled into this study.

The protocol will be conducted at the major vasculitis centers in the United States and Canada participating in selected VCRC studies. Skin biopsy specimens collected as standard of care for these diseases will be retrieved and used in research.

Brief 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 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

Primary outcomes:
measure: Evaluation of clinical data and linked biopsy specimens
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Pennsylvania
name: Robert Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The National Institute of Arthritis and Musculoskeletal and Skin Diseases
name: Peter Grayson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: