Recruiting

Clinical Transcriptomics

Sponsor:

Peter Merkel

Code:

NCT03004326

Conditions

Cryoglobulinemic Vasculitis (CV)

Drug-induced Vasculitis

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

IgA Vasculitis

Isolated Cutaneous Vasculitis

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Cryoglobulinemic Vasculitis (CV)

Drug-induced Vasculitis

Eosinophilic Granulomatosis With Polyangiitis (EGPA)

IgA Vasculitis

Isolated Cutaneous Vasculitis

Study ID

NCT03004326

Start date

Jan, 2017

Status verified date

Jan, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Evaluation of clinical data and linked biopsy specimens [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Carol McAlear, MA

cmcalear@upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Laura Cesar

Laura.Cesar@Pennmedicine.upenn.edu

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Lauren Kuhns

lrk9t@uvahealth.org

St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada

Contacts

Sandra Messier

smessier@stjoes.ca

University of Toronto Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Nazrana Haq

Nazrana.Haq@sinaihealth.ca

More Information

Sponsor

Peter Merkel

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • DIV
  • CSS
  • EGPA
  • HSP
  • GPA
  • MPA
  • PAN
  • Wegeners

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Peter Merkel on 2026-01-22.