Clinical Transcriptomics in Systemic Vasculitis (CUTIS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Peter Merkel
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Evaluation of clinical data and linked biopsy specimens
研究概览
简要总结
Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluation of clinical data and linked biopsy specimens
时间窗: 1 year
Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.
次要结局
未报告次要终点
研究者
Peter Merkel
Chief, Division of Rheumatology Professor of Medicine and Epidemiology
University of Pennsylvania