Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003108
NCT ID: NCT03004326
Sponsor Protocol Number: VCRC5563
About this study
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator David Wetter, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available