NCT03004326 Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
| NCT ID | NCT03004326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peter Merkel |
| Condition | Cryoglobulinemic Vasculitis (CV) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2017-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2017-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.
Eligibility Criteria
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
Contact & Investigator
Carol McAlear, MA
✉ cmcalear@upenn.eduRobert Micheletti, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT03004326 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Cryoglobulinemic Vasculitis (CV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03004326 currently recruiting?
Yes, NCT03004326 is actively recruiting participants. Contact the research team at cmcalear@upenn.edu for enrollment information.
Where is the NCT03004326 trial being conducted?
This trial is being conducted at Los Angeles, United States, Boston, United States, Rochester, United States, Cleveland, United States and 6 additional locations.
Who is sponsoring the NCT03004326 clinical trial?
NCT03004326 is sponsored by Peter Merkel. The principal investigator is Robert Micheletti, MD at University of Pennsylvania. The trial plans to enroll 50 participants.