Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorPeter Merkel

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis

Cryoglobulinemic vasculitis (CV)

Drug-induced vasculitis

Eosinophilic granulomatosis with polyangiitis (EGPA)

Disqualifiers

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

Trial population

About 56 people with vasculitis will take part in this study at approximately 20 medical centers across North America. Patients with CV, DiV, EGPA, IgA vasculitis, GPA, MPA, PAN, isolated cutaneous vasculitis and urticarial vasculitis will potentially be enrolled into this study. The protocol will be conducted at the major vasculitis centers in the United States and Canada participating in selected VCRC studies. Skin biopsy specimens collected as standard of care for these diseases will be retrieved and used in research.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Evaluation of clinical data and linked biopsy specimens

Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter Merkel

Lead sponsor

University of Pennsylvania

Sponsor institution

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

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Office of Rare Diseases Research (ORDR)

Collaborator