SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 505
- 试验地点
- 16
- 主要终点
- tolerance of each type of biopsy
研究概览
简要总结
Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.
详细描述
patinets that benefited of arterial temporal biospy or salivary gland biospy or muscuar biopsy or neuro muscular biospy for his auto -mmune disease will be included and fill standardized questionnaires concerning tolerance, information and side effect at inclusion , day 7 and day 30 after the biopsy data will be analysed to evaluate information, tolerance and risk factor af side effect
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •biospy required for the diagnsis or follow up aged of more than 18 non opposition form
排除标准
- •unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate
结局指标
主要结局
tolerance of each type of biopsy
时间窗: tolerance at day 7 after the biospy was performed
tolerance based on a standardized patient 's questionnaire
次要结局
- tolerance of each type of biopsy 30 days after(tolerance at day 30 and at inclusion after the biospy was performed)
- evaluation of the qualitiy of patient's information at inclusion(questionnaire at inclusion)
- risk factor of sied effect of each biospy(standardized questionnaire at inclusion, day 7 and 30)