<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/NCT03232242</url>
  </required_header>
  <id_info>
    <org_study_id>KY2017-338</org_study_id>
    <nct_id>NCT03232242</nct_id>
  </id_info>
  <brief_title>Application of NGS Technique in Precise Diagnosis of Infectious Diseases</brief_title>
  <official_title>Application of Next Generation Sequencing Technique in Precise Diagnosis of Infectious Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Jiao Tong University Affiliated Sixth People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huashan Hospital</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>
      Infectious disease leads to deaths that accounted for more than 25% of all causes of human&#xD;
      mortality. But the traditional microbiological diagnostic methods such as specimen culture&#xD;
      are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and&#xD;
      viruses may be difficult to cultivate and isolation. Therefore, the accurate identification&#xD;
      and rapid classification of pathogenic microorganisms is very important for the patient's&#xD;
      precise diagnosis and timely treatment.&#xD;
&#xD;
      Small-scale studies on the diagnostic efficacy and prognosis of infection in the next&#xD;
      generation have been shown to provide early diagnosis and targeted medication guidance for&#xD;
      bloodstream infections and respiratory infections, but the larger-scale validation of&#xD;
      next-generation sequencing Technology in the diagnosis and treatment of infectious diseases&#xD;
      in the human body is relatively rare.&#xD;
&#xD;
      The purpose of this study is to provide rapid etiological diagnosis of patients by means of&#xD;
      next-generation sequencing, to change the way of treatment of patients under the existing&#xD;
      traditional pathogen detection by means of accurate description of pathogens and monitoring&#xD;
      their dynamic changes, and to provide patients with more accurate treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</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>Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of infectious diseases</measure>
    <time_frame>3 years</time_frame>
    <description>We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Next-generation sequencing will be performed on the collected samples. Our analysis of the sequencing results will focus on the analysis and identification of pathogen genes and will compare the diagnostic performance of next-generation sequencing with conventional etiological diagnostic methods. We anticipate that next-generation sequencing in infectious patients will show a greater diagnostic value than the traditional methods (including culture, special pathogen serology, PCR detection of nucleic acids, etc.).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases</measure>
    <time_frame>3 years</time_frame>
    <description>We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Traditional methods including culture, special pathogen serology, PCR detection of nucleic acids, etc, will be performed on the collected samples. Our analysis aims to study the diagnostic power of the traditional diagnostic methods in infectious diseases.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Next Generation Sequencing</condition>
  <condition>Infectious Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Next-generation sequencing</intervention_name>
    <description>To provide rapid etiological diagnosis of patients by means of next-generation sequencing.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that are highly suspected of infectious diseases, and they will be selected mainly&#xD;
        from infectious diseases departments .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are highly suspected of fever of unknown origin&#xD;
&#xD;
          -  Patients are highly suspected of bloodstream infection&#xD;
&#xD;
          -  Patients are highly suspected of respiratory infections&#xD;
&#xD;
          -  Patients are highly suspected of central nervous system infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed as non-infectious diseases such as cancer and autoimmune diseases;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wenhong Zhang, PhD,MD</last_name>
    <phone>+86 21 52889999</phone>
    <phone_ext>8123</phone_ext>
    <email>zhangwenhong@fudan.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jialin Jin, PhD,MD</last_name>
    <phone>+86 15601957225</phone>
    <email>jinjialin2002@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Huashan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenhong Zhang, PhD,MD</last_name>
      <phone>+86 21 52889999</phone>
      <phone_ext>8123</phone_ext>
      <email>zhangwenhong@fudan.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</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>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</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/NCT03232242
org study id: KY2017-338
nct id: NCT03232242
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Infectious disease leads to deaths that accounted for more than 25% of all causes of human
      mortality. But the traditional microbiological diagnostic methods such as specimen culture
      are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and
      viruses may be difficult to cultivate and isolation. Therefore, the accurate identification
      and rapid classification of pathogenic microorganisms is very important for the patient's
      precise diagnosis and timely treatment.

      Small-scale studies on the diagnostic efficacy and prognosis of infection in the next
      generation have been shown to provide early diagnosis and targeted medication guidance for
      bloodstream infections and respiratory infections, but the larger-scale validation of
      next-generation sequencing Technology in the diagnosis and treatment of infectious diseases
      in the human body is relatively rare.

      The purpose of this study is to provide rapid etiological diagnosis of patients by means of
      next-generation sequencing, to change the way of treatment of patients under the existing
      traditional pathogen detection by means of accurate description of pathogens and monitoring
      their dynamic changes, and to provide patients with more accurate treatment.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of infectious diseases
time frame: 3 years
description: We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Next-generation sequencing will be performed on the collected samples. Our analysis of the sequencing results will focus on the analysis and identification of pathogen genes and will compare the diagnostic performance of next-generation sequencing with conventional etiological diagnostic methods. We anticipate that next-generation sequencing in infectious patients will show a greater diagnostic value than the traditional methods (including culture, special pathogen serology, PCR detection of nucleic acids, etc.).
measure: Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases
time frame: 3 years
description: We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Traditional methods including culture, special pathogen serology, PCR detection of nucleic acids, etc, will be performed on the collected samples. Our analysis aims to study the diagnostic power of the traditional diagnostic methods in infectious diseases.
intervention type: Diagnostic Test
intervention name: Next-generation sequencing
description: To provide rapid etiological diagnosis of patients by means of next-generation sequencing.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wenhong Zhang, PhD,MD
phone: +86 21 52889999
phone ext: 8123
email: zhangwenhong@fudan.edu.cn
last name: Jialin Jin, PhD,MD
phone: +86 15601957225
email: jinjialin2002@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Wen-hong Zhang
investigator title: Director
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No