Clinical trial NCT02969213: Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China
Official title: Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Electronic management of epilepsy
biological etiology
Chinese children
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 10000
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 0-14 years old epilepsy patients in China

Brief summary: The purpose of this study is to develop the electronic management platform for children with epilepsy, establish large data of Chinese children with epilepsy and explore its biological etiology.

Detailed description: The establishment of the electronic management platform for children with epilepsy and large data of epilepsy in Chinese children as well as the epidemiological study its biological etiology.

Eligibility criteria: Inclusion Criteria:

* Children with epilepsy diagnosis, seizure types and causes of disease classification in accordance with the International Association for the diagnosis and treatment of epilepsy in 2015 guidelines
* Epilepsy children Included 0-14 years old from outpatients and inpatients by the Children's epilepsy specialist using iGrowSys management platform and clinical research, and medical records data entry complete in all China

Exclusion Criteria:

* The patients that recorded data is not complete, telephone and communication address unknown
* The patients that families do not have Internet or children and families will not access the Internet, can not be online operation

Primary outcomes:
measure: The data of over 10 thousand childhood epilepsy patients in China
timeFrame: 26 month after developing a public platform for electronic analysis and management
Secondary outcomes:
measure: Incidence of several different causes of children epilepsy in China
timeFrame: up to 26 months
Other outcomes:
measure: gene mutation
timeFrame: 30 days after receipt of DNA sample
measure: immune factors
timeFrame: 7days after receipt of blood sample or/and cerebrospinal fluid
measure: metabolic factors
timeFrame: 7days after receipt of blood sample or/and urine
measure: structural factors
timeFrame: 5ays after patients see doctor
measure: Infection factors
timeFrame: 7days after receipt of blood sample, urine and cerebrospinal fluid
Locations:
city: Shanghai
country: China
facility: Ling Li
Study officials:
References:
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