<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/NCT03271567</url>
  </required_header>
  <id_info>
    <org_study_id>TB Protocol ver.1</org_study_id>
    <nct_id>NCT03271567</nct_id>
  </id_info>
  <brief_title>Nanodisk-MS Assay for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients</brief_title>
  <official_title>Detection of Circulating Mycobacterium Tuberculosis Antigen Peptides for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis in Hospitalized Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prince of Wales Hospital, Shatin, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alice Ho Miu Ling Nethersole Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading&#xD;
      to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and&#xD;
      molecular techniques, which have limitations including low sensitivity and high cost.Highly&#xD;
      sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to&#xD;
      aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis&#xD;
      (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This&#xD;
      study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to&#xD;
      detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or&#xD;
      extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to&#xD;
      the School of Biological and Health Systems Engineering, Arizona State University, for&#xD;
      detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic&#xD;
      target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations,&#xD;
      including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be&#xD;
      performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass&#xD;
      spectrometry (MS) assay will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic test correlation</measure>
    <time_frame>One year from the date of recruitment</time_frame>
    <description>Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of Nanodisk-MS assay, in diagnosing &quot;culture-positive&quot; and &quot;culture-negative&quot; pulmonary and/or extrapulmonary TB.</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Active Tuberculosis</condition>
  <condition>Tuberculosis, Extrapulmonary</condition>
  <condition>Tuberculosis, Pulmonary</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nanodisk-MS assay</intervention_name>
    <description>Nanodisk-MS assay is a recently reported novel assay for quantitative detection of various MTB antigen peptides, using nanotechnology and mass spectrometry that showed remarkable sensitivity and specificity in diagnosing active pulmonary and extrapulmonary TB. This assay detected MTB-specific antigens, CFP-10 and ESAT-6, in patients' serum samples.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the Prince of Wales Hospital and the Alice Ho Miu Ling Nethersole&#xD;
        Hospital with suspected pulmonary and extrapulmonary TB will be identified by Infectious&#xD;
        Diseases physician and recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients aged 18 or above,&#xD;
&#xD;
          -  Assessed by an Infectious Diseases physician to have clinical and/or radiological&#xD;
             suspicion of pulmonary and/or extrapulmonary TB.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to consent from patients or next of kins for incompetent patients.&#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_official>
    <last_name>Chung Yan Grace Lui</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Liu C, Zhao Z, Fan J, Lyon CJ, Wu HJ, Nedelkov D, Zelazny AM, Olivier KN, Cazares LH, Holland SM, Graviss EA, Hu Y. Quantification of circulating Mycobacterium tuberculosis antigen peptides allows rapid diagnosis of active disease and treatment monitoring. Proc Natl Acad Sci U S A. 2017 Apr 11;114(15):3969-3974. doi: 10.1073/pnas.1621360114. Epub 2017 Mar 27.</citation>
    <PMID>28348223</PMID>
  </reference>
  <reference>
    <citation>Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.</citation>
    <PMID>24642794</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Grace Lui</investigator_full_name>
    <investigator_title>Associate consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Tuberculosis, Pulmonary</mesh_term>
    <mesh_term>Tuberculosis, Extrapulmonary</mesh_term>
  </condition_browse>
  <!-- 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/NCT03271567
org study id: TB Protocol ver.1
nct id: NCT03271567
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diagnosis and treatment of tuberculosis are often delayed in hospitalized patients, leading
      to worse outcomes. Rapid diagnosis of tuberculosis currently relies on microscopy and
      molecular techniques, which have limitations including low sensitivity and high cost.Highly
      sensitive diagnostic technique is needed for more accurate rapid diagnosis of tuberculosis to
      aid earlier initiation of antituberculous therapy. Detection of Mycobacterium tuberculosis
      (MTB) antigens in the bloodstream can potentially allow early diagnosis of tuberculosis. This
      study aims to evaluate the diagnostic performance of a novel assay using nanotechnology to
      detect MTB antigens in patients admitted to hospital with suspected pulmonary and/or
      extrapulmonary tuberculosis. Blood will be taken from eligible patients, and will be sent to
      the School of Biological and Health Systems Engineering, Arizona State University, for
      detection of 10-kDa culture filtrate protein (CFP-10) and the 6 kDa early secretory antigenic
      target (ESAT-6), two antigens specific for MTB, using the Nanodisk-MS assay. Investigations,
      including microscopy, culture, MTB polymerase chain reaction (PCR), and imaging, will be
      performed for diagnosis of tuberculosis. The diagnostic performance of Nanodisk-mass
      spectrometry (MS) assay will be evaluated.
observational model: Case-Only
time perspective: Prospective
measure: Diagnostic test correlation
time frame: One year from the date of recruitment
description: Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of Nanodisk-MS assay, in diagnosing "culture-positive" and "culture-negative" pulmonary and/or extrapulmonary TB.
intervention type: Diagnostic Test
intervention name: Nanodisk-MS assay
description: Nanodisk-MS assay is a recently reported novel assay for quantitative detection of various MTB antigen peptides, using nanotechnology and mass spectrometry that showed remarkable sensitivity and specificity in diagnosing active pulmonary and extrapulmonary TB. This assay detected MTB-specific antigens, CFP-10 and ESAT-6, in patients' serum samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chung Yan Grace Lui
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
citation: Liu C, Zhao Z, Fan J, Lyon CJ, Wu HJ, Nedelkov D, Zelazny AM, Olivier KN, Cazares LH, Holland SM, Graviss EA, Hu Y. Quantification of circulating Mycobacterium tuberculosis antigen peptides allows rapid diagnosis of active disease and treatment monitoring. Proc Natl Acad Sci U S A. 2017 Apr 11;114(15):3969-3974. doi: 10.1073/pnas.1621360114. Epub 2017 Mar 27.
PMID: 28348223
citation: Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.
PMID: 24642794
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Grace Lui
investigator title: Associate consultant
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Tuberculosis, Extrapulmonary