xml: <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/NCT06033807</url>
    </required_header>
    <id_info>
      <org_study_id>TB-Youth Screening</org_study_id>
      <nct_id>NCT06033807</nct_id>
    </id_info>
    <brief_title>Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients</brief_title>
    <official_title>Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huashan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Guizhou Center for Disease Control and Prevention</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Huashan Hospital</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>
        The goal of this observational study is to investigate the proportion of Mycobacterium&#xD;
        tuberculosis (MTB) infection in school contacts of active tuberculosis (ATB) patients. The&#xD;
        main questions it aims to answer are:&#xD;
  &#xD;
          -  the proportion of MTB infection among school contacts of ATB patients&#xD;
  &#xD;
          -  risk factors related to tuberculosis (TB) infection&#xD;
  &#xD;
          -  health economic evaluation of screening strategy&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 12, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>The prevalence of tuberculosis (TB) infection in school contacts</measure>
      <time_frame>baseline</time_frame>
      <description>The prevalence of TB infection is defined as the number of participants with positive results in QuantiFERON-TB Gold (QFT) test in study population. Positive result in QFT test indicates higher response than the cut-off value of 0.35 IU / ml of INF-γ detected in at least one test tube (TB1 or TB2).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>baseline</time_frame>
      <description>Age as possible risk factor of tuberculosis infection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sex</measure>
      <time_frame>baseline</time_frame>
      <description>Sex as possible risk factor of tuberculosis infection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vaccination history checklist</measure>
      <time_frame>baseline</time_frame>
      <description>Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patterns of contacting checklist</measure>
      <time_frame>baseline</time_frame>
      <description>Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Co-morbidities / medical history checklist</measure>
      <time_frame>baseline</time_frame>
      <description>Co-morbidities / medical history [cardiovascular disease, bronchial asthma, digestive ulcer, nephritic syndrome, glomerulonephritis, diabetes, hyperthyroidism, systemic lupus erythematosus, ankylosing spondylitis, epilepsy, schizophrenia, depression, HIV infection, glucocorticoid use, biologic agent use, immunosuppressive agent use, or other relevant co-morbidities / medical history]; as possible risk factor of tuberculosis infection.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">31440</enrollment>
    <condition>Tuberculosis</condition>
    <condition>Latent Tuberculosis Infection</condition>
    <arm_group>
      <arm_group_label>Contacts</arm_group_label>
      <description>School contacts of ATB patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>QuantiFERON-TB Gold (QFT) test</intervention_name>
      <description>Participants will be tested by QuantiFERON-TB Gold (QFT) test to see if they have ever infected by MTB. Those with positive results will proceed to sputum Xpert MTB/RIF, physical examination and chest CT scan, as well as sputum culture if necessary to distinguish latent TB infection (LTBI) from ATB. X-ray scan is conditional on age above 15 years with a positive QuantiFERON-TB Gold (QFT) test result.</description>
      <arm_group_label>Contacts</arm_group_label>
      <other_name>Chest CT Scan</other_name>
      <other_name>Chest X-ray Scan</other_name>
      <other_name>Sputum Culture</other_name>
      <other_name>Sputum Xpert MTB/RIF</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Students in junior middle schools, high schools and universities from Guizhou Province,&#xD;
          China&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  13 years old or above;&#xD;
  &#xD;
            -  Students in junior middle school, high school and university;&#xD;
  &#xD;
            -  Close contact of school active tuberculosis case (e.g. in the same classroom, in the&#xD;
               same dormitory);&#xD;
  &#xD;
            -  Himself/herself (together with his/her guardian for age under 18 years old) willing to&#xD;
               participate in trial and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current clinical or sputum culture confirmed active tuberculosis&#xD;
  &#xD;
            -  Have completed a full course of treatment for ATB or LTBI&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wenhong Zhang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huashan Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qiaoling Ruan, PhD</last_name>
      <phone>13661856002</phone>
      <email>ruan_qiao_ling@fudan.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jinlan Li, MPH</last_name>
      <phone>13985045080</phone>
      <email>740820442@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dafang Center for Disease Control and Prevention</name>
        <address>
          <city>Bijie</city>
          <state>Guizhou</state>
          <zip>551600</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daochun Wan</last_name>
        <phone>15284642890</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qixingguan Center for Disease Control and Prevention</name>
        <address>
          <city>Bijie</city>
          <state>Guizhou</state>
          <zip>551700</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chenglin Wang</last_name>
        <phone>13595758657</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nayong Center for Disease Control and Prevention</name>
        <address>
          <city>Bijie</city>
          <state>Guizhou</state>
          <zip>553307</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Quan Li</last_name>
        <phone>13984788462</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Liping Center for Disease Control and Prevention</name>
        <address>
          <city>Linping</city>
          <state>Guizhou</state>
          <zip>557300</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhibo Xu</last_name>
        <phone>18984510861</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Qingzhen Center for Disease Control and Prevention</name>
        <address>
          <city>Qingzhen</city>
          <state>Guizhou</state>
          <zip>551400</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yan Guo</last_name>
        <phone>15885026866</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Huashan Hospital</investigator_affiliation>
      <investigator_full_name>Wen-hong Zhang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>latent tuberculosis</keyword>
    <keyword>active screening</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Tuberculosis</mesh_term>
      <mesh_term>Latent Tuberculosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033807
  org study id: TB-Youth Screening
  nct id: NCT06033807
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to investigate the proportion of Mycobacterium
        tuberculosis (MTB) infection in school contacts of active tuberculosis (ATB) patients. The
        main questions it aims to answer are:
  
          -  the proportion of MTB infection among school contacts of ATB patients
  
          -  risk factors related to tuberculosis (TB) infection
  
          -  health economic evaluation of screening strategy
  observational model: Other
  time perspective: Cross-Sectional
  measure: The prevalence of tuberculosis (TB) infection in school contacts
  time frame: baseline
  description: The prevalence of TB infection is defined as the number of participants with positive results in QuantiFERON-TB Gold (QFT) test in study population. Positive result in QFT test indicates higher response than the cut-off value of 0.35 IU / ml of INF-γ detected in at least one test tube (TB1 or TB2).
  measure: Age
  time frame: baseline
  description: Age as possible risk factor of tuberculosis infection
  measure: Sex
  time frame: baseline
  description: Sex as possible risk factor of tuberculosis infection.
  measure: Vaccination history checklist
  time frame: baseline
  description: Bacillus Calmette-Guérin (BCG) vaccination history as possible risk factor of tuberculosis infection.
  measure: Patterns of contacting checklist
  time frame: baseline
  description: Duration, size of space of exposure to active tuberculosis-infected patient; as possible risk factor of tuberculosis infection.
  measure: Co-morbidities / medical history checklist
  time frame: baseline
  description: Co-morbidities / medical history [cardiovascular disease, bronchial asthma, digestive ulcer, nephritic syndrome, glomerulonephritis, diabetes, hyperthyroidism, systemic lupus erythematosus, ankylosing spondylitis, epilepsy, schizophrenia, depression, HIV infection, glucocorticoid use, biologic agent use, immunosuppressive agent use, or other relevant co-morbidities / medical history]; as possible risk factor of tuberculosis infection.
  arm group label: Contacts
  description: School contacts of ATB patients
  intervention type: Diagnostic Test
  intervention name: QuantiFERON-TB Gold (QFT) test
  description: Participants will be tested by QuantiFERON-TB Gold (QFT) test to see if they have ever infected by MTB. Those with positive results will proceed to sputum Xpert MTB/RIF, physical examination and chest CT scan, as well as sputum culture if necessary to distinguish latent TB infection (LTBI) from ATB. X-ray scan is conditional on age above 15 years with a positive QuantiFERON-TB Gold (QFT) test result.
  arm group label: Contacts
  other name: Chest CT Scan
  other name: Chest X-ray Scan
  other name: Sputum Culture
  other name: Sputum Xpert MTB/RIF
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wenhong Zhang, PhD
  role: Principal Investigator
  affiliation: Huashan Hospital
  last name: Qiaoling Ruan, PhD
  phone: 13661856002
  email: ruan_qiao_ling@fudan.edu.cn
  last name: Jinlan Li, MPH
  phone: 13985045080
  email: 740820442@qq.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Huashan Hospital
  investigator full name: Wen-hong Zhang
  investigator title: Professor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Tuberculosis
  mesh term: Latent Tuberculosis
  sharing ipd: No
  ipd description: This research targets adolescent students in school. We decide not to share IPD from the ethical perspective.