<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/NCT03799653</url>
  </required_header>
  <id_info>
    <org_study_id>KYH2019-002</org_study_id>
    <nct_id>NCT03799653</nct_id>
  </id_info>
  <brief_title>A Nurse Cohort Study in Xiamen, China</brief_title>
  <official_title>A Prospective Cohort Study of Common Chronic Diseases on Nurses in Xiamen, China: Nurse Cohort Study Xiamen (NCSX)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Xiamen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Xiamen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The Nurse Cohort Study Xiamen (NCSX) is an open-ended prospective cohort study with very&#xD;
      broad research aims. The primary objectives of the NCSX is planned to examine genetic,&#xD;
      epigenetic, biological, psychological, social, lifestyle and other environmental factors of&#xD;
      nurses in relation to incidence and progression of the common chronic diseases, such as&#xD;
      hypertension, ischemic heart disease, stroke, diabetes, chronic kidney disease and some&#xD;
      cancers, which are emerging with economic development in Xiamen, China. Specifically, we&#xD;
      intend to test whether empirically driven hypothesis and emerging risk factors mainly&#xD;
      developed in response to observations in economically developed Western societies apply in a&#xD;
      population living in a rapid changing lifestyle in China now.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To establish a cohort of about 10,000 registered nurses (aged 20 or over) in&#xD;
      Xiamen, China; to describe the baseline major risk factors; to analyze their&#xD;
      interrelationships; and to examine the risks of incidence and progression of major chronic&#xD;
      diseases, such as hypertension, stroke, CKD and cancers, and all-cause and cause-specific&#xD;
      mortality by different levels of the risk factors after about 5 years follow-up.&#xD;
&#xD;
      Design: A prospective cohort study. Setting: 7 public hospitals in Xiamen, China.&#xD;
      Participants: About 10,000 registered nurses (aged 20 or over) who work in public hospitals&#xD;
      in Xiamen, China.&#xD;
&#xD;
      Main outcome: Incidences of common chronic diseases, such as CVD, diabetes, chronic kidney&#xD;
      disease, and cancers; progression of these diseases; all cause and specific-cause mortality.&#xD;
&#xD;
      Hypothesis: Relative risks of major risk factors. Results of the study should have strong&#xD;
      impact on prevention and control of these diseases and promoting nurses'health in the local&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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 rate</measure>
    <time_frame>2019.1.21-2024.12.31</time_frame>
    <description>The incidence rates of common chronic diseases, such as hypertension, The stroke, CKD and cancers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>2019.1.21-2024.12.31</time_frame>
    <description>All-cause and cause-specific mortality</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Nurses</arm_group_label>
    <description>All subjects are registered nurses in Xiamen, China</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is a prospective observational study, and there is no intervention.</description>
    <arm_group_label>Nurses</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, plasma and urin.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  Registered nurses in public hospitals in Xiamen, China;&#xD;
&#xD;
          -  Aged 20 years or over and living in Xiamen for at least 1 year and will not move out&#xD;
             of Xiamen for at least 5 years;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Registered nurses of public hospitals in Xiamen, China;&#xD;
&#xD;
          -  aged 20 years or over;&#xD;
&#xD;
          -  Working in the public hospitals for at least 1 year;&#xD;
&#xD;
          -  Signed the informed consent and agreed to participate in the study;&#xD;
&#xD;
          -  Assuming not moved out of Xiamen for at least 5 years;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who are unambulatory;&#xD;
&#xD;
          -  who are receiving treatment modalities, which , if omitted, may result in immediate&#xD;
             life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for&#xD;
             renal failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Weihua Li, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Xiamen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhibin Li, Ph.D.</last_name>
    <phone>86592-2137364</phone>
    <email>zhibinli33@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Haihua Zhu, Master</last_name>
    <phone>86592-2137278</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhibin Li, Ph.D.</last_name>
      <phone>86592-2137364</phone>
      <email>zhibinli33@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Xiamen University</investigator_affiliation>
    <investigator_full_name>Zhibin LI</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT03799653
org study id: KYH2019-002
nct id: NCT03799653
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Nurse Cohort Study Xiamen (NCSX) is an open-ended prospective cohort study with very
      broad research aims. The primary objectives of the NCSX is planned to examine genetic,
      epigenetic, biological, psychological, social, lifestyle and other environmental factors of
      nurses in relation to incidence and progression of the common chronic diseases, such as
      hypertension, ischemic heart disease, stroke, diabetes, chronic kidney disease and some
      cancers, which are emerging with economic development in Xiamen, China. Specifically, we
      intend to test whether empirically driven hypothesis and emerging risk factors mainly
      developed in response to observations in economically developed Western societies apply in a
      population living in a rapid changing lifestyle in China now.
Objectives: To establish a cohort of about 10,000 registered nurses (aged 20 or over) in
      Xiamen, China; to describe the baseline major risk factors; to analyze their
      interrelationships; and to examine the risks of incidence and progression of major chronic
      diseases, such as hypertension, stroke, CKD and cancers, and all-cause and cause-specific
      mortality by different levels of the risk factors after about 5 years follow-up.

      Design: A prospective cohort study. Setting: 7 public hospitals in Xiamen, China.
      Participants: About 10,000 registered nurses (aged 20 or over) who work in public hospitals
      in Xiamen, China.

      Main outcome: Incidences of common chronic diseases, such as CVD, diabetes, chronic kidney
      disease, and cancers; progression of these diseases; all cause and specific-cause mortality.

      Hypothesis: Relative risks of major risk factors. Results of the study should have strong
      impact on prevention and control of these diseases and promoting nurses'health in the local
      population.
observational model: Cohort
time perspective: Prospective
measure: Incidence rate
time frame: 2019.1.21-2024.12.31
description: The incidence rates of common chronic diseases, such as hypertension, The stroke, CKD and cancers
measure: Mortality
time frame: 2019.1.21-2024.12.31
description: All-cause and cause-specific mortality
arm group label: Nurses
description: All subjects are registered nurses in Xiamen, China
intervention type: Other
intervention name: No intervention
description: This is a prospective observational study, and there is no intervention.
arm group label: Nurses
serum, plasma and urin.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Weihua Li, Ph.D.
role: Study Chair
affiliation: The First Affiliated Hospital of Xiamen University
last name: Zhibin Li, Ph.D.
phone: 86592-2137364
email: zhibinli33@hotmail.com
last name: Haihua Zhu, Master
phone: 86592-2137278
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Xiamen University
investigator full name: Zhibin LI
investigator title: Director
mesh term: Hypertension
sharing ipd: Undecided