Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

NCT03004326 — Recruiting, 50 participants, Peter Merkel

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RegistryNCT03004326, acronym CUTIS
StatusRecruiting
Study typeObservational
Enrollment50 (Estimated)
SponsorPeter Merkel (Other); collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), Office of Rare Diseases Research (ORDR)
ConditionsCryoglobulinemic 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
Datesstart 2017-01-01, primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2016-12-28, last updated 2026-01-22
Locations10 sites in United States, Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Cryoglobulinemic Vasculitis (CV) All trials for Drug-induced Vasculitis

-Summary

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

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+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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 5 Years to any

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

+Locations (10)

FacilityCityCountryStatus
University of California, Los AngelesLos Angeles, CaliforniaUnited StatesCompleted
Boston University School of MedicineBoston, MassachusettsUnited StatesCompleted
Mayo ClinicRochester, MinnesotaUnited StatesCompleted
Cleveland ClinicCleveland, OhioUnited StatesCompleted
Oregon Health & Science UniversityPortland, OregonUnited StatesCompleted
University of PennsylvaniaPhiladelphia, PennsylvaniaUnited StatesRecruiting
University of UtahSalt Lake City, UtahUnited StatesCompleted
University of VirginiaCharlottesville, VirginiaUnited StatesRecruiting
St. Joseph's HealthcareHamilton, OntarioCanadaRecruiting
University of Toronto Mount Sinai HospitalToronto, OntarioCanadaRecruiting

+Investigators

+Funding

NIH grants: U54AR057319