Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China

November 17, 2016 updated by: Ling Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200092
        • Ling Li
        • Contact:
        • Contact:
        • Principal Investigator:
          • Feng X Li, PhD
        • Principal Investigator:
          • Yang Tao, bachelor
        • Principal Investigator:
          • Ke D He, PhD
        • Sub-Investigator:
          • Jing Wu, master
        • Sub-Investigator:
          • Jian Xu, PhD
        • Sub-Investigator:
          • Xin Ge, master
        • Sub-Investigator:
          • Mei Y Yan, PhD
        • Sub-Investigator:
          • Lin R Hou, PhD
        • Sub-Investigator:
          • Jia Cao, PhD
        • Sub-Investigator:
          • Feng D Xu, PhD student
        • Sub-Investigator:
          • Jie Z Zhang, PhD student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

0-14 years old epilepsy patients in China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Genetic
patients with Gene detection (+)
Metabolism
patients with Metabolic disturbance
Immune
patients with Immunological marker and Immunotherapy (+)
infection
patients with the Infection of central nervous system
structure
patients with abnormal image of brain
unknown
patients not found any reason

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The data of over 10 thousand childhood epilepsy patients in China
Time Frame: 26 month after developing a public platform for electronic analysis and management
To develop a public platform for electronic analysis and management of children epilepsy to doctors and patients in China
26 month after developing a public platform for electronic analysis and management

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of several different causes of children epilepsy in China
Time Frame: up to 26 months
A surveillance mechanism will be developed to identify and recruit children with epilepsy from the public platform for electronic analysis management of children epilepsy for doctors and patients
up to 26 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
gene mutation
Time Frame: 30 days after receipt of DNA sample
To detect the mutation and characterize the genetic architecture and risk variants of epilepsy using genomic methods
30 days after receipt of DNA sample
immune factors
Time Frame: 7days after receipt of blood sample or/and cerebrospinal fluid
To test Inflammatory factors, Autoimmune antibodies , Immunoglobulin
7days after receipt of blood sample or/and cerebrospinal fluid
metabolic factors
Time Frame: 7days after receipt of blood sample or/and urine
To test tandem mass spectrometry and enzyme
7days after receipt of blood sample or/and urine
structural factors
Time Frame: 5ays after patients see doctor
To scan head MRI
5ays after patients see doctor
Infection factors
Time Frame: 7days after receipt of blood sample, urine and cerebrospinal fluid
To test various pathogen
7days after receipt of blood sample, urine and cerebrospinal fluid

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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