Understanding the Aetiology and Pathogenesis of Giant Cell Arteritis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Phenotyping of innate lymphoid cells (ILC) in the arterial wall and blood of patients with GCA
研究概览
简要总结
Giant Cell Arteritis (GCA) is the most common vasculitis and has significant morbidity in terms of blindness, stroke, and tissue necrosis. It requires protracted treatment with high-dose steroids, and despite this there is a risk of flare during the treatment. Little is known about the initial triggers for the inflammatory process, and there are no good markers of response or relapse. We will study patients referred with suspected GCA to identify important components of the immune response in GCA, and follow them over time to collect evidence of how best to monitor their condition.
详细描述
Objectives and Study Plan:
Study Purpose:
The purpose of the study is to investigate the underlying immunological processes in GCA and to study the pattern of expression of immune response over time to give us information about how best to monitor GCA.
End Point:
The end point will be the final visit of the final patient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or over
- •A clinical suspicion of a new diagnosis of GCA e.g. patients with a new onset of headache, scalp tenderness, with or without elevated CRP or ESR, jaw or tongue claudication with or without visual loss
- •Participants must be willing to give informed written consent or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities e.g. sudden onset of blindness/vision loss which can be caused by GCA (this will be made clear in the ethics approval application)
排除标准
- •Previous diagnosis of GCA
- •Long term (>1 month) high dose (>20mg per day at any time) steroids for conditions other than PMR, within three months prior to study entry
- •Inability to give informed consent (either written consent or verbal assent from a relative or carer)
结局指标
主要结局
Phenotyping of innate lymphoid cells (ILC) in the arterial wall and blood of patients with GCA
时间窗: 24 months
Arterial biopsy tissue and peripheral blood will be collected from patients with suspected GCA. A proportion of these will be diagnosed with GCA and will be the "test" subjects, and a proportion will be diagnosed with other conditions that are not GCA and will be the "controls". We will use immunohistochemistry and immunofluorescence microscopy to locate and phenotype ILC in arterial biopsies. We will use semi-quantitative methods (ie cells per random high powered field) to compare prevalence of ILC in tests and controls. We will also isolate peripheral blood mononuclear cells (PBMCs) from fresh whole blood, and stain the cells to use flow cytometry to quantify and phenotype the ILC. Tests and Controls will be compared using Mann-Whitney statistical testing.
次要结局
- Archiving of tissue for future studies(60 months+)
- CD70 in GCA(12 months)
- IL-7 and sIL-7R in GCA(36 months)
- Vascular Endothelial Growth Factor (VEGF) levels over time(36 months)
- Pentraxin 3 levels over time(36 months)