NCT06760091尚未招募不适用
Multicentric Registry Study of Autoimmune Encephalitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in modified Rankin score (mRS) from baseline
研究概览
简要总结
This study aims to establish an autoimmune encephalitis cohort and observe the prognosis of patients with different subtypes and subgroups (e.g. epilepsy subgroup and teratoma subgroup ). Clinical characteristics, biological samples, and imaging data will be collected to discover blood and imaging biomarkers for providing support for the treatment, early warning, and outcome prediction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender and age are not limited;
- •Newly diagnosed autoimmune encephalitis according to at least one of the following three criteria:
- •According to the criteria of Graus et al in 2016, diagnosed as "definite autoimmune limbic encephalitis"
- •According to the criteria of Graus et al in 2016, diagnosed as "possible autoimmune encephalitis" and typical autoantibodies are detected in serum or cerebrospinal fluid
- •According to the criteria of Graus et al in 2021, diagnosed as "possible or definite paraneoplastic neurological syndrome" (excluding peripheral nervous system syndrome)
- •The patient or legal representative voluntarily signed the paper informed consent form.
- •Additional inclusion criteria for patients in the epilepsy subgroup: patients diagnosed with epilepsy secondary to autoimmune encephalitis.
排除标准
- •No additional exclusion criteria
结局指标
主要结局
Change in modified Rankin score (mRS) from baseline
时间窗: 3months, 6 months, 12months, 24months
Change in modified Rankin score (mRS) from baseline at month 1, month 3, month 6(mRS : Minimum Score 0, Maximum score 6, higher scores mean a worse outcome).
次要结局
- Proportion of Subjects With Occurrence(12 months, 24 months)
- Change of Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score from Baseline(3months, 6 months, 12months, 24months)
- Changes of pathogenic antibody titers from baseline(3months, 6 months, 12months, 24months)
研究者
研究点 (1)
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