ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease
Epilepsy

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
Estimated Enrollment : 10000 participants
Time Perspective: Retrospective
Official Title: Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. immune factors [ Time Frame: 7days after receipt of blood sample or/and cerebrospinal fluid ]
    To test Inflammatory factors, Autoimmune antibodies , Immunoglobulin

  3. metabolic factors [ Time Frame: 7days after receipt of blood sample or/and urine ]
    To test tandem mass spectrometry and enzyme

  4. structural factors [ Time Frame: 5ays after patients see doctor ]
    To scan head MRI

  5. Infection factors [ Time Frame: 7days after receipt of blood sample, urine and cerebrospinal fluid ]
    To test various pathogen



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
0-14 years old epilepsy patients in China
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969213


Locations
China
Ling Li Not yet recruiting
Shanghai, China, 200092
Contact: Ling Li, PhD    13651715616    linglidoctor@163.com   
Contact: Mei Yu Yan, PhD    15800793973    yanyumei_020601@163.com   
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         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications of Results:

Other Publications:
Responsible Party: Ling Li, chief physician,proffessor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02969213     History of Changes
Other Study ID Numbers: XH-16-029
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ling Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Electronic management of epilepsy
biological etiology
Chinese children

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases