Estimate of the Activity and the Forecast of the Lupus Disease of the Adult by a Transcriptomic Score (STUDY LU-PUCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Identify the genes expressed during the disease to allow the calculation of a transcriptomic score and study the correlation of this transcriptionnal score with the SLEDAI score
研究概览
简要总结
Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of which remains very difficult because of an heterogeneousness of the clinical and biological symptoms. The aim of this study is to develop objective, specific and not invasive methods of evaluation of the activity and the forecast of the disease by using an analysis of the transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by the usual clinico-biological follow-up at the patients affected by systemic lupus, while the diagnosis before treatment, then during every revaluation of the disease during the period of the study. The already treated patients can also be included in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lupus disease diagnosed for lupus disease arm
- •Signed assent
排除标准
- •non-compliance
- •pregnancy
- •persons without social coverage
研究组 & 干预措施
Lupus disease
干预措施: blood sample (Biological)
Healthy witnesses
干预措施: blood sample (Biological)
Healthy witnesses with an other auto-immune disease
干预措施: blood sample (Biological)
结局指标
主要结局
Identify the genes expressed during the disease to allow the calculation of a transcriptomic score and study the correlation of this transcriptionnal score with the SLEDAI score
时间窗: 2 years
次要结局
- Identify genes correlated in various histological classes of lupus renal disease and types of pushes of the disease; to allow the calculation of a transcriptomic score and its correlation with the BILAG score(2 years)