<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/NCT03288805</url>
  </required_header>
  <id_info>
    <org_study_id>2017YFC0907100</org_study_id>
    <nct_id>NCT03288805</nct_id>
  </id_info>
  <brief_title>Cohort Study in South China</brief_title>
  <official_title>Prospective Cohort Study of Chronic Diseases in South China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Min Xia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hainan Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou No.12 People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Fifth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy Chinese residents from South China will be recruited and followed up for at least 4&#xD;
      years to evaluate the association between climate, diet and lifestyle and risks for the&#xD;
      development of chronic diseases. Physical examination, questionnaire survey and biological&#xD;
      sample collection will be conducted at baseline and the incidence of chronic diseases will be&#xD;
      investigated during follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      110,000 adult Chinese (35 to 74 years old) without chronic diseases and major disability who&#xD;
      have been living in South China including Guangdong, Fujian, Guangxi and Hainan for more than&#xD;
      5 years will be recruited. All participants will be prospectively followed up for the&#xD;
      incidence of chronic diseases (stroke, coronary heart disease, malignant neoplasms, chronic&#xD;
      obstructive pulmonary diseases, diabetes and hypertension) and their risk factors (impaired&#xD;
      glucose tolerance and obesity). Information about socio-demographic, diet, lifestyle,&#xD;
      psychological status, medical history and current medication will be collected by&#xD;
      questionnaires. Physical examinations including height, weight, waist and hip circumferences,&#xD;
      blood pressure, fat mass and vital capacity will be conducted. Besides, blood, urine and&#xD;
      fecal samples will be collected for further analysis. Annual meteorological data throughout&#xD;
      the study period will also be collected. The associations between climate, diet and lifestyle&#xD;
      and risks for chronic diseases will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of chronic disease</measure>
    <time_frame>4 years</time_frame>
    <description>Incidence of chronic disease, including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for chronic diseases</measure>
    <time_frame>4 years</time_frame>
    <description>Incidence of impaired glucose tolerance and obesity</description>
  </secondary_outcome>
  <enrollment type="Anticipated">110000</enrollment>
  <condition>Chronic Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum ,Urine and fecal samples for biochemical tests, biomarker examination and DNA&#xD;
      extraction&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Chinese (35-74 years old) who have been living in South China including Guangdong,&#xD;
        Fujian, Guangxi and Hainan provinces for more than 5 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult Chinese (35-74 years old) who have been living in South China including&#xD;
             Guangdong, Fujian, Guangxi and Hainan provinces for more than 5 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any subject diagnosed with stroke, coronary heart disease, malignancy, chronic&#xD;
             obstructive pulmonary disease, diabetes and hypertension.&#xD;
&#xD;
          -  any subject who suffer from major disability and cannot participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Xia</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Public Health,Nutrition and Food Hygiene,Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Min Xia</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03288805
org study id: 2017YFC0907100
nct id: NCT03288805
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Healthy Chinese residents from South China will be recruited and followed up for at least 4
      years to evaluate the association between climate, diet and lifestyle and risks for the
      development of chronic diseases. Physical examination, questionnaire survey and biological
      sample collection will be conducted at baseline and the incidence of chronic diseases will be
      investigated during follow-up.
110,000 adult Chinese (35 to 74 years old) without chronic diseases and major disability who
      have been living in South China including Guangdong, Fujian, Guangxi and Hainan for more than
      5 years will be recruited. All participants will be prospectively followed up for the
      incidence of chronic diseases (stroke, coronary heart disease, malignant neoplasms, chronic
      obstructive pulmonary diseases, diabetes and hypertension) and their risk factors (impaired
      glucose tolerance and obesity). Information about socio-demographic, diet, lifestyle,
      psychological status, medical history and current medication will be collected by
      questionnaires. Physical examinations including height, weight, waist and hip circumferences,
      blood pressure, fat mass and vital capacity will be conducted. Besides, blood, urine and
      fecal samples will be collected for further analysis. Annual meteorological data throughout
      the study period will also be collected. The associations between climate, diet and lifestyle
      and risks for chronic diseases will be evaluated.
observational model: Cohort
time perspective: Prospective
measure: Incidence of chronic disease
time frame: 4 years
description: Incidence of chronic disease, including stroke, coronary heart disease, cancer, chronic obstructive pulmonary disease, diabetes and hypertension
measure: Risk factors for chronic diseases
time frame: 4 years
description: Incidence of impaired glucose tolerance and obesity
Serum ,Urine and fecal samples for biochemical tests, biomarker examination and DNA
      extraction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Min Xia
role: Principal Investigator
affiliation: School of Public Health,Nutrition and Food Hygiene,Sun Yat-sen University
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Min Xia
investigator title: Professor
mesh term: Chronic Disease
sharing ipd: No