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 2022
Primary Completion Date
August 2022
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
January 2022