Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Sponsor

Peter Merkel (Other)

Overall Status

Recruiting

CT.gov ID

NCT03004326

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH), National Center for Advancing Translational Science (NCATS) (NIH), Office of Rare Diseases Research (ORDR) (Other)

Enrollment

Locations

Anticipated Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Outcome Measures

Primary Outcome Measures

Evaluation of clinical data and linked biopsy specimens [1 year]
Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Boston University School of Medicine	Boston	Massachusetts	United States	02118
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Cleveland Clinic	Cleveland	Ohio	United States	44195
5	Oregon Health & Science University	Portland	Oregon	United States
6	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
7	University of Utah	Salt Lake City	Utah	United States
8	University of Toronto Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5

Sponsors and Collaborators

Peter Merkel
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Advancing Translational Science (NCATS)
Office of Rare Diseases Research (ORDR)

Investigators

Principal Investigator: Robert Micheletti, MD, University of Pennsylvania
Principal Investigator: Peter Grayson, MD, MSc, The National Institute of Arthritis and Musculoskeletal and Skin Diseases