<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/NCT02219945</url>
  </required_header>
  <id_info>
    <org_study_id>TBDIAGNOSE</org_study_id>
    <secondary_id>KE/FK/859/EC</secondary_id>
    <nct_id>NCT02219945</nct_id>
  </id_info>
  <brief_title>ENOSE in Pulmonary Tuberculosis in Yogyakarta</brief_title>
  <acronym>YOGYATBNOSE</acronym>
  <official_title>The Accuracy of the eNose in the Diagnostics and Monitoring of Treatment of Treatment-naive TB Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tjip van der Werf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gadjah Mada University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Enose Company, Zutphen the Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electronic noses detecting patterns of volatile molecules have recently been introduced for&#xD;
      different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins&#xD;
      et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%.&#xD;
      Here the investigators test a production type point-of-care hand-held device with less&#xD;
      detectors. The investigators explore factors such as food intake, smoking, and co-morbidity,&#xD;
      as well as the impact of TB treatment, and address the question whether the device could help&#xD;
      monitor disease and response to treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants provide WIC and after time for consideration, when they approve, provide&#xD;
      demographic anonymized data.&#xD;
&#xD;
      The study population consists of six groups:&#xD;
&#xD;
      Group 1 - 20 TB patients aged &gt; 18 yrs Group 2 - 20 non---TB patients &gt; 18 yrs (screened for&#xD;
      TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung&#xD;
      Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 -&#xD;
      20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time,&#xD;
      until after end of treatment (8 months FU).&#xD;
&#xD;
      Group 6 - 50 apparently healthy volunteers.&#xD;
&#xD;
      Study participants breath normally by mouthpiece into the device using a nose clamp - for 5&#xD;
      min during each sampling.&#xD;
&#xD;
      Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data&#xD;
      are processed to build the model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>6 groups:&#xD;
1) 20 TB patients 2) 20 non-TB patients (alternative diagnosis) 3) 20 patients with chest symptoms - non-TB 4) 7 MDR-TB patients 5) 20 healthy controls 6) 300 subjects suspected to have pulmonary tuberculosis - follow-up for 2.5 years</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>diagnostic precision of electronic nose signal in pulmonary TB</measure>
    <time_frame>18 months</time_frame>
    <description>sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>measuring response to TB treatment over time with the electronic nose</measure>
    <time_frame>18 months</time_frame>
    <description>cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">389</enrollment>
  <condition>Pulmonary Tuberculosis Suspected</condition>
  <condition>Other Specified Chronic Obstructive Pulmonary Disease</condition>
  <condition>Pulmonary Tuberculosis TB (+) Histology, (-) Bacteriology</condition>
  <arm_group>
    <arm_group_label>Group 1 - 20 PTB patients aged &gt;18yrs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 - 20 TB patients aged &gt; 18 yrs 5 min exhaled breath sampling with nose clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - 20 TB suspects &gt; 18 yrs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 - 20 non-TB patients &gt; 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 3 - 20 lung patients, non-TB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 - 20 healthy controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5 - 7 newly diagnosedMDR PTB pts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 6 - cohort of TB suspects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for &gt;2 years 5 min exhaled breath sampling with nose clamp</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5 min exhaled breath sampling with soft nose clamp</intervention_name>
    <description>study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc</description>
    <arm_group_label>Group 1 - 20 PTB patients aged &gt;18yrs</arm_group_label>
    <arm_group_label>Group 2 - 20 TB suspects &gt; 18 yrs</arm_group_label>
    <arm_group_label>Group 4 - 20 healthy controls</arm_group_label>
    <arm_group_label>Group 5 - 7 newly diagnosedMDR PTB pts</arm_group_label>
    <arm_group_label>group 3 - 20 lung patients, non-TB</arm_group_label>
    <arm_group_label>group 6 - cohort of TB suspects</arm_group_label>
    <other_name>AEONOSE portable exhaled breath sampling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18yrs&#xD;
&#xD;
          -  voluntarily participating&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>patients - at 5 lung clinics (Minggiran, Kalasan, Kotagede, Bantul, Kuonprogo) connected with Sudjarto Teachnig Hospital; healthy controls among students and staff of Hospital and Gadjah Mada Universitas</name>
      <address>
        <city>Yogyakarta</city>
        <state>Jalan Kesehatan no.1, Yogyakarta</state>
        <zip>55281</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>May 31, 2017</last_update_submitted>
  <last_update_submitted_qc>May 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Tjip van der Werf</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pulmonary tuberculosis; electronic nose; diagnostic accuracy</keyword>
  <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>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02219945
org study id: TBDIAGNOSE
secondary id: KE/FK/859/EC
nct id: NCT02219945
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Electronic noses detecting patterns of volatile molecules have recently been introduced for
      different diagnostic purposes. The diagnostic accuracy of a prototype e-nose device (Bruins
      et al (2013) in Bangladesh showed sensitivity of 76.5-95.9% and specificity of 85.3-98.5%.
      Here the investigators test a production type point-of-care hand-held device with less
      detectors. The investigators explore factors such as food intake, smoking, and co-morbidity,
      as well as the impact of TB treatment, and address the question whether the device could help
      monitor disease and response to treatment.
Study participants provide WIC and after time for consideration, when they approve, provide
      demographic anonymized data.

      The study population consists of six groups:

      Group 1 - 20 TB patients aged > 18 yrs Group 2 - 20 non---TB patients > 18 yrs (screened for
      TB - other conditions) Group 3 - 20 patients with a lung disease - no TB suspects (Lung
      Clinics in Yogyakarta,Indonesia; Group 4 - 50 apparently healthy matched controls Group 5 -
      20 newly diagnosed TB patients enrolled before start of treatment, to be followed over time,
      until after end of treatment (8 months FU).

      Group 6 - 50 apparently healthy volunteers.

      Study participants breath normally by mouthpiece into the device using a nose clamp - for 5
      min during each sampling.

      Electronic data are downloaded and transmitted by internet to Zutphen, Netherlands where data
      are processed to build the model.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: 6 groups:
1) 20 TB patients 2) 20 non-TB patients (alternative diagnosis) 3) 20 patients with chest symptoms - non-TB 4) 7 MDR-TB patients 5) 20 healthy controls 6) 300 subjects suspected to have pulmonary tuberculosis - follow-up for 2.5 years
primary purpose: Diagnostic
masking: None (Open Label)
measure: diagnostic precision of electronic nose signal in pulmonary TB
time frame: 18 months
description: sensitivity and specificity of electronic nose signal in diagnosing and measuring response to treatment in pulmonary TB
measure: measuring response to TB treatment over time with the electronic nose
time frame: 18 months
description: cohort of patients newly deteted with PTB will be followed with the enose device over time to monitor disease activity, until end of treatment
arm group label: Group 1 - 20 PTB patients aged >18yrs
arm group type: Experimental
description: Group 1 - 20 TB patients aged > 18 yrs 5 min exhaled breath sampling with nose clamp
arm group label: Group 2 - 20 TB suspects > 18 yrs
arm group type: Experimental
description: Group 2 - 20 non-TB patients > 18 yrs (screened for TB - but appear to test negative for TB, and diagnosed with other conditions including bronchiectasis, etc) 5 min exhaled breath sampling with nose clamp
arm group label: group 3 - 20 lung patients, non-TB
arm group type: Experimental
description: Group 3 - 20 patients with a lung disease - no TB suspects (recruited from Lung Clinics in Yogyakarta; lung cancer, COPD, etc) 5 min exhaled breath sampling with nose clamp
arm group label: Group 4 - 20 healthy controls
arm group type: Experimental
description: Group 4 - 20 apparently healthy matched controls 5 min exhaled breath sampling with nose clamp
arm group label: Group 5 - 7 newly diagnosedMDR PTB pts
arm group type: Experimental
description: Group 5 - 7 newly diagnosed MDRTB patients enrolled before start of treatment, to be followed 8 months, until after end of treatment 5 min exhaled breath sampling with nose clamp
arm group label: group 6 - cohort of TB suspects
arm group type: Experimental
description: 300 more individuals, suspected to have TB - final diagnosis by standard procedures plus sputum culture plus follow-up for >2 years 5 min exhaled breath sampling with nose clamp
intervention type: Other
intervention name: 5 min exhaled breath sampling with soft nose clamp
description: study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
arm group label: Group 1 - 20 PTB patients aged >18yrs
arm group label: Group 2 - 20 TB suspects > 18 yrs
arm group label: Group 4 - 20 healthy controls
arm group label: Group 5 - 7 newly diagnosedMDR PTB pts
arm group label: group 3 - 20 lung patients, non-TB
arm group label: group 6 - cohort of TB suspects
other name: AEONOSE portable exhaled breath sampling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Indonesia
responsible party type: Sponsor-Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Tjip van der Werf
investigator title: Professor
mesh term: Tuberculosis
mesh term: Tuberculosis, Pulmonary
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive