Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

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Brief Title

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Official Title

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

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.
    


Study Type

Observational


Primary Outcome

Evaluation of clinical data and linked biopsy specimens


Condition

Cryoglobulinemic Vasculitis (CV)



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

50

Start Date

January 2017

Completion Date

August 2021

Primary Completion Date

August 2021

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
      

Gender

All

Ages

5 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Micheletti, MD, , [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03004326

Organization ID

VCRC5563

Secondary IDs

U54AR057319

Responsible Party

Sponsor-Investigator

Study Sponsor

Peter Merkel

Collaborators

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

Study Sponsor

Robert Micheletti, MD, Principal Investigator, University of Pennsylvania


Verification Date

May 2021