Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- cytokine/chemokine/metabolite concentrations
研究概览
简要总结
To date, there are no reliable diagnostic blood markers of adult vasculitis. To date, the diagnosis of vasculitis is based on invasive procedure, biopsy of affected tissues potentially at risk of complication . In addition, there are no reliable biomarkers to predict the evolution of vasculitis (relapse, refractory form ...) necessary for the management of patients (type of treatment, duration ..)
Prospective study, monocentric (CHU de Tours), non-interventional, aimed at finding diagnostic and prognostic biomarkers (both metabolomic and immunologic) in adult vasculitis patients.
详细描述
Specimen will be collected at diagnosis, month 1, month 3, and month12 and at the time of a possible relapse. 14 ml of additional blood during a blood puncture made for routine care will be collected at each visit as well as clinical data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years
- •Active vasculitis, new diagnosis or relapse
- •IgA vasculitis
- •ANCA vasculitis
- •Giant cell arteritis
排除标准
- •Person who has objected to the processing of data
- •Pregnant woman
- •Patient positive for HIV, HBV, HCV
- •Treatment in the previous month with corticosteroids, immunosuppressive drugs or biotherapy.
- •Patient unable to understand the information leaflet
- •Adult under guardianship or curatorship
结局指标
主要结局
cytokine/chemokine/metabolite concentrations
时间窗: date of relapse assessed up to 12 months
Analysis by méthod Luminex
percentage of different non-conventional T cell populations
时间窗: date of relapse assessed up to 12 months
study by flow cytometry
次要结局
- cytokine/chemokine/metabolite concentrations(date of relapse assessed up to 12 months)
- percentage of different non-conventional T cell populations(date of relapse assessed up to 12 months)
- metabolomic pathway(date of relapse assessed up to 12 months)
- immunological pathway(date of relapse assessed up to 12 months)