<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/NCT03017183</url>
  </required_header>
  <id_info>
    <org_study_id>WI_EBUS-TBNA_16-226</org_study_id>
    <nct_id>NCT03017183</nct_id>
  </id_info>
  <brief_title>Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy</brief_title>
  <official_title>Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wissenschaftliches Institut Bethanien e.V</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Pathology, University Clinic Düsseldorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wissenschaftliches Institut Bethanien e.V</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study participants will be selected from clinical routine patients with endobronchial&#xD;
      infiltration of a central lung cancer and indication for bronchoscopic sampling.&#xD;
&#xD;
      Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling&#xD;
      methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The&#xD;
      sequence of both sampling methods will be randomized in advance.&#xD;
&#xD;
      The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH.&#xD;
      The corresponding analysis results will be compared between sampling methods.&#xD;
&#xD;
      Assignment of a subject to a particular therapeutic strategy is not influenced by this&#xD;
      protocol. Medicinal products will be used according to current practice and marketing&#xD;
      authorisation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of detected mutations</measure>
    <time_frame>within 7 days after biopsy</time_frame>
    <description>The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>EBUS-TBNA - Endobrochial Forceps Biopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Forceps - EBUS-TBNA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EBUS-TBNA</intervention_name>
    <description>Endobronchial ultrasound guided transbronchial needle aspiration</description>
    <arm_group_label>EBUS-TBNA - Endobrochial Forceps Biopsy</arm_group_label>
    <arm_group_label>Forceps - EBUS-TBNA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endobronchial forceps biopsy</intervention_name>
    <description>Conventional endobronchial forceps biopsy</description>
    <arm_group_label>EBUS-TBNA - Endobrochial Forceps Biopsy</arm_group_label>
    <arm_group_label>Forceps - EBUS-TBNA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Subjects eligible for enrolment in the study must meet all of the following criteria:&#xD;
&#xD;
          1. Informed consent: a signed and dated written informed consent prior to study&#xD;
             participation.&#xD;
&#xD;
          2. Type of subject: inpatient&#xD;
&#xD;
          3. Age: subjects of more than 18 years and less than 85 years.&#xD;
&#xD;
          4. Central lesion in computed tomography highly suspicious of lung cancer with clinical&#xD;
             indication for further diagnostic applying bronchoscopy.&#xD;
&#xD;
          5. Central lesion has to be accessible by the biopsy techniques under investigation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Subjects meeting any of the following criteria must not be enrolled in the study:&#xD;
&#xD;
          1. Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due&#xD;
             to the risk for their child&#xD;
&#xD;
          2. Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR&gt;2, thrombocytopenia&#xD;
             &lt;40/nl)&#xD;
&#xD;
          3. Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform&#xD;
             informed consent.&#xD;
&#xD;
          4. Inability to read or inability of language: in the opinion of the investigator, any&#xD;
             subject who is unable to read and/or would not be able to complete study related&#xD;
             materials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Winfried J Randerath, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wissenschaftliches Institut Bethanien e.V</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Krankenhaus Bethanien gGmbH</name>
      <address>
        <city>Solingen</city>
        <state>NRW</state>
        <zip>42699</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT03017183
org study id: WI_EBUS-TBNA_16-226
nct id: NCT03017183
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Study participants will be selected from clinical routine patients with endobronchial
      infiltration of a central lung cancer and indication for bronchoscopic sampling.

      Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling
      methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The
      sequence of both sampling methods will be randomized in advance.

      The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH.
      The corresponding analysis results will be compared between sampling methods.

      Assignment of a subject to a particular therapeutic strategy is not influenced by this
      protocol. Medicinal products will be used according to current practice and marketing
      authorisation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of detected mutations
time frame: within 7 days after biopsy
description: The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined
arm group label: EBUS-TBNA - Endobrochial Forceps Biopsy
arm group type: Other
description: In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy
arm group label: Forceps - EBUS-TBNA
arm group type: Other
description: In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA
intervention type: Procedure
intervention name: EBUS-TBNA
description: Endobronchial ultrasound guided transbronchial needle aspiration
arm group label: EBUS-TBNA - Endobrochial Forceps Biopsy
arm group label: Forceps - EBUS-TBNA
intervention type: Procedure
intervention name: Endobronchial forceps biopsy
description: Conventional endobronchial forceps biopsy
arm group label: EBUS-TBNA - Endobrochial Forceps Biopsy
arm group label: Forceps - EBUS-TBNA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: Winfried J Randerath, Prof. Dr.
role: Principal Investigator
affiliation: Wissenschaftliches Institut Bethanien e.V
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Lung Neoplasms