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Trial record 16 of 1816 for:    epilepsy

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

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ClinicalTrials.gov Identifier: NCT02969213
Recruitment Status : Not yet recruiting
First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Ling Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date October 19, 2016
First Posted Date November 21, 2016
Last Update Posted Date November 21, 2016
Study Start Date November 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2016)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 17, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 17, 2016)
  • 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
  • immune factors [ Time Frame: 7days after receipt of blood sample or/and cerebrospinal fluid ]
    To test Inflammatory factors, Autoimmune antibodies , Immunoglobulin
  • metabolic factors [ Time Frame: 7days after receipt of blood sample or/and urine ]
    To test tandem mass spectrometry and enzyme
  • structural factors [ Time Frame: 5ays after patients see doctor ]
    To scan head MRI
  • Infection factors [ Time Frame: 7days after receipt of blood sample, urine and cerebrospinal fluid ]
    To test various pathogen
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 0-14 years old epilepsy patients in China
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 17, 2016)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 14 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02969213
Other Study ID Numbers XH-16-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ling Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Sponsor Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Verification Date November 2016