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RecruitingNCT03004326CUTISUpdated Jan 22, 2026

Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

An observational study in Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis and Eosinophilic Granulomatosis With Polyangiitis (EGPA), sponsored by Peter Merkel. Recruiting at 10 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Peter Merkel · Observational

From the registry’s dates

  • Started Jan 2017; still recruiting 9 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
5 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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

Keywords

  • DIV
  • CSS
  • EGPA
  • HSP
  • GPA
  • MPA
  • PAN
  • Wegeners
03

In context

Churg-Strauss Syndrome

61 studies on the registry are indexed under Churg-Strauss Syndrome; 17 are open to participants now.

This study's planned enrollment of 50 is below the median of 239 across 30 observational studies indexed under Churg-Strauss Syndrome.

Browse Churg-Strauss Syndrome studies →

Lead sponsor

Peter Merkel is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (or assent for those under

Exclusion criteria

Exclusion Criteria:

  • You are less than five years old
  • Considered not to be a candidate for a 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 (type of white blood cell) less than 1500/mm3, count less than 50,000/mm3, or a 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

07

Study locations

4 of 10 sites recruiting
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2017 (actual). Primary completion is estimated for Dec 2028, 143 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2016
First posted
Dec 28, 2016
StartActual
Jan 2017
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Jan 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03004326
Lead sponsor
Peter Merkel
Responsible party
Peter Merkel (Chief, Division of Rheumatology Professor of Medicine and Epidemiology, University of Pennsylvania) — Sponsor-investigator
First posted
Dec 28, 2016
Start date
Jan 2017
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 22, 2026

Study contacts

Carol McAlear, MA
Contact
cmcalear@upenn.edu
Robert Micheletti, MD
principal investigator · University of Pennsylvania
Peter Grayson, MD, MSc
principal investigator · The National Institute of Arthritis and Musculoskeletal and Skin Diseases

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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