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Korean medicine Cohort Study: a community-based population in Daejeon, Korea

Status Approved

  • First Submitted Date

    2017/11/27

  • Registered Date

    2019/09/16

  • Last Updated Date

    2019/09/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004297
    Unique Protocol ID DJDSKH-17-BM-12
    Public/Brief Title Korean medicine Cohort Study: a community-based population in Daejeon, Korea
    Scientific Title Korean medicine Cohort Study: a community-based population in Daejeon, Korea
    Acronym Korean medicine Daejeon Citizen Cohort : KDCC
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DJDSKH-17-BM-12
    Approval Date 2017-06-16
    Institutional Review Board Name Institutional Review Board of Dunsan Korean Medicine of Daejeon university
    Institutional Review Board Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-470-9488
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Horyong Yoo
    Title a full professor
    Telephone +82-42-470-9131
    Affiliation Dunsan Korean Medicine Hospital of Daejeon University
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea, Dunsan Hospital
    Contact Person for Public Queries
    Name Younghwa Baek
    Title Researcher
    Telephone +82-42-868-9286
    Affiliation Korea Institute of Oriental Medicine
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea, Dunsan Hospital
    Contact Person for Updating Information
    Name Bok-Nam Seo
    Title Researcher
    Telephone +82-42-869-2788
    Affiliation Korea Institute of Oriental Medicine
    Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea, Dunsan Hospital
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2017-07-10 Actual
    Target Number of Participant 2000
    Primary Completion Date 2025-12-31 , Anticipated
    Study Completion Date 2025-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Daejeon Korean Medicine Hospital of Daejeon University
    Recruitment Status Recruiting
    Date of First Enrollment 2017-07-10 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
    Project ID KC-C-002
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Daejeon Korean Medicine Hospital of Daejeon University
    Organization Type Medical Institute
    2. Sponsor Organization
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1) Establish a community-based Korean medicine cohort by understanding the general health status of the residents of Daejeon, including lifestyle, illness and chronic diseases.
    2) Long-term follow-up observations are conducted to Propose a prevention and treatment technology for chronic diseases that takes into consideration Korean medicine types and individual traits.
    3) Develop a genome-based diagnostic technology using Korean medicine types, such as constitution types and cold-heat patterns. 
    
    The primary outcome in this study is new onset of a CVD, such as myocardial infarction, angina, or stroke during participation, and the endpoint is death from a CVD. The secondary outcome is the onset of chronic diseases, such as metabolic syndrome, hypertension, diabetes mellitus, and dyslipidemia.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 2000
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    General community Population

    Cohort/Group Description

    General characteristics(demographic information, drinking, smoking), disease history, lifestyle (sleep, physical activity, Diet habits), Quality of life, Korean medical information(constitution, heat), vital signs, heart rate variability, body composition test, blood test, etc. We will collect clinical information and the long-term follow-up to identify the impact of chronic diseases.
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample with DNA
    Biospecimen Description
    Blood(serum)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    30 to 55 years old, Healthy people in Daejeon city.
    Sampling Method
    multi-stratified sampling
    Condition(s)/Problem(s)    Not Applicable-Quality of life 

    Not Applicable
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    30Year~55Year

    Description

    ① The person who are between 30 and 55 years of age
     ② The person living in daejeon city
     ③ The person agreed to participate after hearing the explanation of the purpose and content of the study
    Exclusion Criteria
    ① The person who have been diagnosed with cancer (malignant tumor), cardiovascular disease (myocardial infarction, angina pectoris, stroke)
     ② The person who is difficult to comply with the question answer and understanding
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Prevalence of Cardiovascular Disease
    Timepoint
    At every visit(Once every two years)
    Secondary Outcome(s) 1
    Outcome
    Prevalence of non-infectious chronic diseases (metabolic syndrome, hypertension, diabetes and dyslipidemia)
    Timepoint
    At every visit(Once every two years)
    Secondary Outcome(s) 2
    Outcome
    a genome-based diagnostic technology using Korean medicine types, such as constitution types and cold-heat patterns
    Timepoint
    At every visit(Once every two years)
    Secondary Outcome(s) 3
    Outcome
    Health status(Quality of life, the Mibyeong(deterioration of the health)and lifestyle variable
    Timepoint
    At every visit(Once every two years)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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