Cryoglobulinemic Vasculitis (CV)CUTISNCT03004326
Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
An observational study of Cryoglobulinemic Vasculitis (CV) and Drug-induced Vasculitis, run by Peter Merkel at 10 sites in 2 countries.
Trial summary
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
- How many people
- 50 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2017to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Carol McAlear, MA contact
10 sites in 2 countries
United States8 sites, 2 recruiting
- Completed
Boston University School of Medicine
Boston, Massachusetts, 02118
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Lauren Kuhns, lrk9t@uvahealth.org
- Completed
Cleveland Clinic
Cleveland, Ohio, 44195
- Completed
University of California, Los Angeles
Los Angeles, California, 90095
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Laura Cesar, Laura.Cesar@Pennmedicine.upenn.edu
- Completed
Oregon Health & Science University
Portland, Oregon
- Completed
Mayo Clinic
Rochester, Minnesota, 55905
- Completed
University of Utah
Salt Lake City, Utah
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton, Ontario
Sandra Messier, smessier@stjoes.ca
- Recruiting
University of Toronto Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Nazrana Haq, Nazrana.Haq@sinaihealth.ca
About this study
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.
- Conditions
- Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), IgA Vasculitis, Isolated Cutaneous Vasculitis, Granulomatosis With Polyangiitis (GPA)
- Keywords
- DIV, CSS, EGPA, HSP, GPA, MPA, PAN, Wegeners
- Medical subject headings
- Cryoglobulinemia, Familial Mixed, Churg-Strauss Syndrome, IgA Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Polyarteritis Nodosa, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical data and linked biopsy specimens
Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryoglobulinemic Vasculitis (CV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Merkel
- Sponsor type
- University, hospital or 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)
- Responsible party
- Sponsor-investigator, Peter Merkel, University of Pennsylvania
- Investigators
- Robert Micheletti, MD, Principal investigator, University of PennsylvaniaPeter Grayson, MD, MSc, Principal investigator, The National Institute of Arthritis and Musculoskeletal and Skin Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004326
- Sponsor's protocol ID
- VCRC5563
- Other IDs
- U54AR057319
- Acronym
- CUTIS
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2016
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
- ClinicalTrials.gov ID
- NCT03004326
- Acronym / sponsor ID
- CUTIS / VCRC5563
- Conditions
- Cryoglobulinemic Vasculitis (CV), Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), IgA Vasculitis, Isolated Cutaneous Vasculitis, Granulomatosis With Polyangiitis (GPA)
- Keywords
- DIV, CSS, EGPA, HSP, GPA, MPA, PAN, Wegeners
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peter MerkelUniversity, hospital or 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)
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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:
- Be willing and able to provide written informed consent (or assent for those under
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of clinical data and linked biopsy specimens
Time frame: 1 year
Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Related InfoLink provided by the sponsor.
Related trials for Cryoglobulinemic Vasculitis (CV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carol McAlear, MA contact
Robert Micheletti, MD principal investigator
University of Pennsylvania
Peter Grayson, MD, MSc principal investigator
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryoglobulinemic Vasculitis (CV) and Drug-induced Vasculitis, run by Peter Merkel at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol McAlear, MA (cmcalear@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical data and linked biopsy specimens (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.