Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data / DEE-RETRO
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- Identification of diagnostic and early predictive biomarkers of a neurodevelopmental trajectory with epileptic and developmental encephalopathies
研究概览
简要总结
Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.
The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Developmental and Epileptic Encephalopathy
- •Registered with or benefiting from a social security scheme.
排除标准
- •Opposition of the patient or his/her parents to the re-use of data in the context of this study
- •Person subject to a safeguard of justice measure
结局指标
主要结局
Identification of diagnostic and early predictive biomarkers of a neurodevelopmental trajectory with epileptic and developmental encephalopathies
时间窗: Data 2002-2026
This composite outcome includes multiple diagnostic domains (Clinical, biological, radiological, genetic and electroencephalographic variables)
次要结局
- Assessment of patients' quality of life(Data 2002-2026)
- Identification of patient subgroups presenting the identified biomarkers(Data 2002-2026)
- Assessment of autism spectrum disorders(Data 2002-2026)
- Assessment of age-related adaptive behavior(Data 2002-2026)
- Assessment of behavioral disorders(Data 2002-2026)