Swiss Pediatric Inflammatory Bain Disease Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Diagnosis
研究概览
简要总结
The Swiss-Ped-IBrainD is a national patient registry that collects information on diagnosis, symptoms, treatment, and follow-up of pediatric patients with an inflammatory brain disease in Switzerland. It was first implemented in 2020 in the pediatric clinic of the university hospital in Bern. Further centers all over Switzerland opened for recruitment after that: Aarau, Basel, Bellinzona, Chur, Geneva, Lausanne, Lucerne, St. Gallen, Winterthur and Zurich. The center in Fribourg is expected open for recruitment in 2025. The registry provides data for national and international monitoring and research. It supports research on inflammatory brain diseases in Switzerland and the exchange of knowledge between clinicians, researchers, and therapists. The registry aims to improve the treatment of children with inflammatory brain diseases and optimizing their health care and quality of life.
详细描述
Background:
Pediatric onset MS and other inflammatory brain diseases (IBrainDs) are severe diseases affecting children and adolescents in a period of essential brain development. This possibly leads to a variety of focal neurological deficits as well as early cognitive impairment. In turn, the cognitive impairment may impact school performance and vocational achievements.
Timely diagnosis and treatment initiation as well as individually tailored management are important for a favorable disease course. However, the diagnosis of the different IBrainDs can be challenging, especially in young children, since their first acute inflammation is often accompanied by unspecific symptoms common to all IBrainDs. A systematic assessment of similarities and differences between clinical signs, symptoms, and diagnostic workup of different IBrainDs will enable faster and more reliable diagnosis.
Furthermore, neither epidemiological data nor information on health care management and disease outcome of pediatric IBrainD patients exist in Switzerland. Therefore, a national registry is being established, which will allow a deeper understanding of pediatric IBrainD epidemiology, clinical presentation, and management. Ultimately, the registry will improve the care of children suffering from an IBrainD in Switzerland.
The Swiss-Ped-IBrainD Registry (title: "Swiss Pediatric Inflammatory Brain Disease Cohort Study", project number: 2019-00377) has been approved by the ethics committees of Bern, the Ethikkommission Nordwest- und Zentralschweiz (EKNZ), the Ethikkommission Ostschweiz (EKOS), and the ethics committees of Zürich, Lausanne, Geneva, and Bellinzona.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 36 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients living and/or treated in Switzerland with an IBrainD specified in the following list diagnosed from 2005 onward and with a disease onset before the age of
- •Written informed consent by patients (and/or legal representative(s), if applicable)
- •Optic Neuritis
- •Transverse Myelitis
- •Acute disseminated encephalomyelitis
- •Multiple Sclerosis
- •Neuromyelitis Optica Spectrum Disorders
- •Myelin oligodendrocyte glycoprotein antibody-associated disease
- •Anti-NMDA-R Encephalitis
- •Anti-GAD65 Associated Autoimmune Encephalitis
- •Anti-AMPAR-1/2 Associated Autoimmune Encephalitis
- •Anti-Lgi-1 Associated Autoimmune Encephalitis
- •Anti-CASPR-2 Associated Autoimmune Encephalitis
- •Anti-GABAR-1/2 Associated Autoimmune Encephalitis
- •Onconeuronal Antibody (Hu, Ri, Yo, Amphiphysin, CRMP-5, Ma-1, Ma-2, SOX-1) Associated Autoimmune Encephalitis
- •Hashimoto Encephalopathy
- •CNS Vasculitis
- •CNS Sarcoidosis
- •CNS Lupus
- •Rasmussen Encephalitis
排除标准
- •Neurological symptoms due to infectious diseases of the CNS
- •Genetic/metabolic causes of central demyelinating diseases
- •Neurological symptoms due to Guillain-Barré-Syndrome
结局指标
主要结局
Diagnosis
时间窗: Until reaching of adulthood (0 to 18 years)
Diagnosis of IBrainD
Age at first symptoms
时间窗: Until reaching of adulthood (0 to 18 years)
Age at first symptoms
Change in Education
时间窗: Until reaching of adulthood (0 to 18 years)
Evolution of education over time
Age at diagnosis
时间窗: Until reaching of adulthood (0 to 18 years)
Age at diagnosis (months and years)
Death cause
时间窗: Life-long; Up to 80 years
Cause of death
Change in EDSS
时间窗: Until reaching of adulthood (0 to 18 years)
EDSS change over time
Change in medication
时间窗: Until reaching of adulthood (0 to 18 years)
Change of IBrainD medication over time
Diagnostic delay
时间窗: Until reaching of adulthood (0 to 18 years)
Time elapsed between symptom-onset and diagnosis (days)
Hospitalization
时间窗: Until reaching of adulthood (0 to 18 years)
Length of hospitalization at diagnosis or during a relapse (days)
Electrophysiological testing
时间窗: Until reaching of adulthood (0 to 18 years)
Assessment if the patient did undergo electrophysiological testing.
First symptoms
时间窗: Until reaching of adulthood (0 to 18 years)
Symptoms before diagnosis
Death date
时间窗: Life-long; Up to 80 years
Date of death
Change in MRI data
时间窗: Until reaching of adulthood (0 to 18 years)
Change in activity of CNS lesions
Change in laboratory test data
时间窗: Until reaching of adulthood (0 to 18 years)
Change in diagnostic markers
Personal data
时间窗: At registration (Life-long; Up to 80 years)
Registering patient's personal data
Rehabilitation
时间窗: Until reaching of adulthood (0 to 18 years)
Length and type of rehabilitation at diagnosis or during a relapse (days)
Change in Neurostatus
时间窗: Until reaching of adulthood (0 to 18 years)
Neurostatus change over time
次要结局
- Future questionnaires(Life-long; Up to 80 years; Will mainly concern childhood (until reaching of adulthood; 0 to 18 years))