Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

  • STATUS
    Recruiting
  • End date
    Aug 25, 2021
  • participants needed
    50
  • sponsor
    Peter Merkel
Updated on 25 January 2021
vasculitis
purpura
polyarteritis nodosa
churg-strauss syndrome
microscopic polyangiitis
granulomatosis
urticarial vasculitis
cryoglobulinemic vasculitis
iga vasculitis

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.

Details
Condition Vasculitis, Vascular Diseases, Wegener's Granulomatosis, Polyarteritis Nodosa, Churg-Strauss Syndrome, Microscopic Polyangiitis, Eosinophilic Granulomatosis With Polyangiitis, Granulomatosis With Polyangiitis, Cryoglobulinemic Vasculitis, IgA Vasculitis, Urticarial Vasculitis, Drug-induced Vasculitis, Isolated Cutaneous Vasculitis, Drug-induced Vasculitis, Drug-induced Vasculitis, Drug-induced Vasculitis, Drug-induced Vasculitis, Drug-induced Vasculitis
Clinical Study IdentifierNCT03004326
SponsorPeter Merkel
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 5 yrs?
Gender: Male or Female
Do you have any of these conditions: Eosinophilic Granulomatosis With Polyangiitis or Urticarial Vasculitis or Vascular Diseases or Vasculitis or Granulomatosis With Polyangiitis or Micro...?
Do you have any of these conditions: Vasculitis or Granulomatosis With Polyangiitis or Drug-induced Vasculitis or Wegener's Granulomatosis or Urticarial Vasculitis or Cryoglobulinemic Vas...?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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