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
CRIS Registration Number |
KCT0004297 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Research Institute |
Project ID | KC-C-002 |
6. Sponsor Organization
1. Sponsor Organization | |
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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
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. |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | 30 to 55 years old, Healthy people in Daejeon city. |
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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)
Type of Primary Outcome | Not applicable | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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