<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02969213</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-029</org_study_id>
    <nct_id>NCT02969213</nct_id>
  </id_info>
  <brief_title>Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China</brief_title>
  <official_title>Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop the electronic management platform for children with&#xD;
      epilepsy, establish large data of Chinese children with epilepsy and explore its biological&#xD;
      etiology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The establishment of the electronic management platform for children with epilepsy and large&#xD;
      data of epilepsy in Chinese children as well as the epidemiological study its biological&#xD;
      etiology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The data of over 10 thousand childhood epilepsy patients in China</measure>
    <time_frame>26 month after developing a public platform for electronic analysis and management</time_frame>
    <description>To develop a public platform for electronic analysis and management of children epilepsy to doctors and patients in China</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of several different causes of children epilepsy in China</measure>
    <time_frame>up to 26 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <other_outcome>
    <measure>gene mutation</measure>
    <time_frame>30 days after receipt of DNA sample</time_frame>
    <description>To detect the mutation and characterize the genetic architecture and risk variants of epilepsy using genomic methods</description>
  </other_outcome>
  <other_outcome>
    <measure>immune factors</measure>
    <time_frame>7days after receipt of blood sample or/and cerebrospinal fluid</time_frame>
    <description>To test Inflammatory factors, Autoimmune antibodies , Immunoglobulin</description>
  </other_outcome>
  <other_outcome>
    <measure>metabolic factors</measure>
    <time_frame>7days after receipt of blood sample or/and urine</time_frame>
    <description>To test tandem mass spectrometry and enzyme</description>
  </other_outcome>
  <other_outcome>
    <measure>structural factors</measure>
    <time_frame>5ays after patients see doctor</time_frame>
    <description>To scan head MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Infection factors</measure>
    <time_frame>7days after receipt of blood sample, urine and cerebrospinal fluid</time_frame>
    <description>To test various pathogen</description>
  </other_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Genetic</arm_group_label>
    <description>patients with Gene detection (+)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metabolism</arm_group_label>
    <description>patients with Metabolic disturbance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immune</arm_group_label>
    <description>patients with Immunological marker and Immunotherapy (+)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>infection</arm_group_label>
    <description>patients with the Infection of central nervous system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>structure</arm_group_label>
    <description>patients with abnormal image of brain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>unknown</arm_group_label>
    <description>patients not found any reason</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        0-14 years old epilepsy patients in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with epilepsy diagnosis, seizure types and causes of disease classification&#xD;
             in accordance with the International Association for the diagnosis and treatment of&#xD;
             epilepsy in 2015 guidelines&#xD;
&#xD;
          -  Epilepsy children Included 0-14 years old from outpatients and inpatients by the&#xD;
             Children's epilepsy specialist using iGrowSys management platform and clinical&#xD;
             research, and medical records data entry complete in all China&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients that recorded data is not complete, telephone and communication address&#xD;
             unknown&#xD;
&#xD;
          -  The patients that families do not have Internet or children and families will not&#xD;
             access the Internet, can not be online operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ling Li</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Ling Li, PhD</last_name>
      <phone>13651715616</phone>
      <email>linglidoctor@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Mei Yu Yan, PhD</last_name>
      <phone>15800793973</phone>
      <email>yanyumei_020601@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Feng X Li, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang Tao, bachelor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ke D He, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jing Wu, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jian Xu, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xin Ge, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mei Y Yan, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lin R Hou, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jia Cao, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Feng D Xu, PhD student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jie Z Zhang, PhD student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sauro KM, Wiebe S, Dunkley C, Janszky J, Kumlien E, Moshe S, Nakasato N, Pedley TA, Perucca E, Senties H, Thomas SV, Wang Y, Wilmshurst J, Jette N. The current state of epilepsy guidelines: A systematic review. Epilepsia. 2016 Jan;57(1):13-23. doi: 10.1111/epi.13273. Epub 2015 Dec 10.</citation>
    <PMID>26659723</PMID>
  </reference>
  <results_reference>
    <citation>Singh A, Trevick S. The Epidemiology of Global Epilepsy. Neurol Clin. 2016 Nov;34(4):837-847. doi: 10.1016/j.ncl.2016.06.015.</citation>
    <PMID>27719996</PMID>
  </results_reference>
  <results_reference>
    <citation>Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.</citation>
    <PMID>23329469</PMID>
  </results_reference>
  <results_reference>
    <citation>Coles LD, Patterson EE, Sheffield WD, Mavoori J, Higgins J, Michael B, Leyde K, Cloyd JC, Litt B, Vite C, Worrell GA. Feasibility study of a caregiver seizure alert system in canine epilepsy. Epilepsy Res. 2013 Oct;106(3):456-60. doi: 10.1016/j.eplepsyres.2013.06.007. Epub 2013 Aug 18.</citation>
    <PMID>23962794</PMID>
  </results_reference>
  <results_reference>
    <citation>Tzallas AT, Tsipouras MG, Rigas G, Tsalikakis DG, Karvounis EC, Chondrogiorgi M, Psomadellis F, Cancela J, Pastorino M, Waldmeyer MT, Konitsiotis S, Fotiadis DI. PERFORM: a system for monitoring, assessment and management of patients with Parkinson's disease. Sensors (Basel). 2014 Nov 11;14(11):21329-57. doi: 10.3390/s141121329.</citation>
    <PMID>25393786</PMID>
  </results_reference>
  <results_reference>
    <citation>Larner AJ. Teleneurology: an overview of current status. Pract Neurol. 2011 Oct;11(5):283-8. doi: 10.1136/practneurol-2011-000090.</citation>
    <PMID>21921003</PMID>
  </results_reference>
  <results_reference>
    <citation>Hani AJ, Mikati HM, Mikati MA. Genetics of pediatric epilepsy. Pediatr Clin North Am. 2015 Jun;62(3):703-22. doi: 10.1016/j.pcl.2015.03.013.</citation>
    <PMID>26022171</PMID>
  </results_reference>
  <results_reference>
    <citation>Bearden D, Strong A, Ehnot J, DiGiovine M, Dlugos D, Goldberg EM. Targeted treatment of migrating partial seizures of infancy with quinidine. Ann Neurol. 2014 Sep;76(3):457-61. doi: 10.1002/ana.24229. Epub 2014 Jul 26.</citation>
    <PMID>25042079</PMID>
  </results_reference>
  <results_reference>
    <citation>Wright S, Vincent A. Progress in autoimmune epileptic encephalitis. Curr Opin Neurol. 2016 Apr;29(2):151-7. doi: 10.1097/WCO.0000000000000304.</citation>
    <PMID>26886357</PMID>
  </results_reference>
  <results_reference>
    <citation>Patel J, Mercimek-Mahmutoglu S. Epileptic Encephalopathy in Childhood: A Stepwise Approach for Identification of Underlying Genetic Causes. Indian J Pediatr. 2016 Oct;83(10):1164-74. doi: 10.1007/s12098-015-1979-9. Epub 2016 Jan 29.</citation>
    <PMID>26821542</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim EH, Ko TS. Cognitive impairment in childhood onset epilepsy: up-to-date information about its causes. Korean J Pediatr. 2016 Apr;59(4):155-64. doi: 10.3345/kjp.2016.59.4.155. Epub 2016 Apr 30.</citation>
    <PMID>27186225</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonello M, Michael BD, Solomon T. Infective Causes of Epilepsy. Semin Neurol. 2015 Jun;35(3):235-44. doi: 10.1055/s-0035-1552619. Epub 2015 Jun 10.</citation>
    <PMID>26060903</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ling Li</investigator_full_name>
    <investigator_title>chief physician,proffessor</investigator_title>
  </responsible_party>
  <keyword>Electronic management of epilepsy</keyword>
  <keyword>biological etiology</keyword>
  <keyword>Chinese children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02969213
org study id: XH-16-029
nct id: NCT02969213
lead sponsor: 
has dmc: No
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.
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.
time perspective: Retrospective
measure: 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
description: To develop a public platform for electronic analysis and management of children epilepsy to doctors and patients in China
measure: Incidence of several different causes of children epilepsy in China
time frame: up to 26 months
description: 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
measure: gene mutation
time frame: 30 days after receipt of DNA sample
description: To detect the mutation and characterize the genetic architecture and risk variants of epilepsy using genomic methods
measure: immune factors
time frame: 7days after receipt of blood sample or/and cerebrospinal fluid
description: To test Inflammatory factors, Autoimmune antibodies , Immunoglobulin
measure: metabolic factors
time frame: 7days after receipt of blood sample or/and urine
description: To test tandem mass spectrometry and enzyme
measure: structural factors
time frame: 5ays after patients see doctor
description: To scan head MRI
measure: Infection factors
time frame: 7days after receipt of blood sample, urine and cerebrospinal fluid
description: To test various pathogen
arm group label: Genetic
description: patients with Gene detection (+)
arm group label: Metabolism
description: patients with Metabolic disturbance
arm group label: Immune
description: patients with Immunological marker and Immunotherapy (+)
arm group label: infection
description: patients with the Infection of central nervous system
arm group label: structure
description: patients with abnormal image of brain
arm group label: unknown
description: patients not found any reason
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 14 Years
healthy volunteers: No
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
citation: Sauro KM, Wiebe S, Dunkley C, Janszky J, Kumlien E, Moshe S, Nakasato N, Pedley TA, Perucca E, Senties H, Thomas SV, Wang Y, Wilmshurst J, Jette N. The current state of epilepsy guidelines: A systematic review. Epilepsia. 2016 Jan;57(1):13-23. doi: 10.1111/epi.13273. Epub 2015 Dec 10.
PMID: 26659723
citation: Singh A, Trevick S. The Epidemiology of Global Epilepsy. Neurol Clin. 2016 Nov;34(4):837-847. doi: 10.1016/j.ncl.2016.06.015.
PMID: 27719996
citation: Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.
PMID: 23329469
citation: Coles LD, Patterson EE, Sheffield WD, Mavoori J, Higgins J, Michael B, Leyde K, Cloyd JC, Litt B, Vite C, Worrell GA. Feasibility study of a caregiver seizure alert system in canine epilepsy. Epilepsy Res. 2013 Oct;106(3):456-60. doi: 10.1016/j.eplepsyres.2013.06.007. Epub 2013 Aug 18.
PMID: 23962794
citation: Tzallas AT, Tsipouras MG, Rigas G, Tsalikakis DG, Karvounis EC, Chondrogiorgi M, Psomadellis F, Cancela J, Pastorino M, Waldmeyer MT, Konitsiotis S, Fotiadis DI. PERFORM: a system for monitoring, assessment and management of patients with Parkinson's disease. Sensors (Basel). 2014 Nov 11;14(11):21329-57. doi: 10.3390/s141121329.
PMID: 25393786
citation: Larner AJ. Teleneurology: an overview of current status. Pract Neurol. 2011 Oct;11(5):283-8. doi: 10.1136/practneurol-2011-000090.
PMID: 21921003
citation: Hani AJ, Mikati HM, Mikati MA. Genetics of pediatric epilepsy. Pediatr Clin North Am. 2015 Jun;62(3):703-22. doi: 10.1016/j.pcl.2015.03.013.
PMID: 26022171
citation: Bearden D, Strong A, Ehnot J, DiGiovine M, Dlugos D, Goldberg EM. Targeted treatment of migrating partial seizures of infancy with quinidine. Ann Neurol. 2014 Sep;76(3):457-61. doi: 10.1002/ana.24229. Epub 2014 Jul 26.
PMID: 25042079
citation: Wright S, Vincent A. Progress in autoimmune epileptic encephalitis. Curr Opin Neurol. 2016 Apr;29(2):151-7. doi: 10.1097/WCO.0000000000000304.
PMID: 26886357
citation: Patel J, Mercimek-Mahmutoglu S. Epileptic Encephalopathy in Childhood: A Stepwise Approach for Identification of Underlying Genetic Causes. Indian J Pediatr. 2016 Oct;83(10):1164-74. doi: 10.1007/s12098-015-1979-9. Epub 2016 Jan 29.
PMID: 26821542
citation: Kim EH, Ko TS. Cognitive impairment in childhood onset epilepsy: up-to-date information about its causes. Korean J Pediatr. 2016 Apr;59(4):155-64. doi: 10.3345/kjp.2016.59.4.155. Epub 2016 Apr 30.
PMID: 27186225
citation: Bonello M, Michael BD, Solomon T. Infective Causes of Epilepsy. Semin Neurol. 2015 Jun;35(3):235-44. doi: 10.1055/s-0035-1552619. Epub 2015 Jun 10.
PMID: 26060903
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Ling Li
investigator title: chief physician,proffessor
mesh term: Epilepsy
sharing ipd: Undecided