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/NCT05992740</url>
    </required_header>
    <id_info>
      <org_study_id>bronchoscope in lung cancer</org_study_id>
      <nct_id>NCT05992740</nct_id>
    </id_info>
    <brief_title>Role of Bronchoscope in Diagnosis of Lung Cancer</brief_title>
    <official_title>The Optimal Sequence of Bronchial Brushing, Forceps Biopsy and Washing for Diagnosis of Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study aims to compare the diagnostic yields of bronchial brushing performed before and&#xD;
        after forceps biopsy and bronchial wash performed before and after biopsy during flexible&#xD;
        bronchoscopy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lung cancer is the most common cause of cancer-related mortality in both sexes in the world.&#xD;
        To treat the disease successfully, it should be diagnosed at the earliest possible stage.&#xD;
        Several studies have demonstrated that early detection, localization, and aggressive&#xD;
        treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy&#xD;
        is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been&#xD;
        developed using flexible fiber-optic bronchoscopy (FOB).&#xD;
  &#xD;
        Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable&#xD;
        diagnostic yields ranging from37-77%. One reason for this variability is limitations in&#xD;
        tissue sampling techniques, which can make it impossible to obtain the most representative&#xD;
        area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including&#xD;
        bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and&#xD;
        transbronchial needle aspiration, have been evaluated in various combinations to improve the&#xD;
        diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence&#xD;
        of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear&#xD;
        and requires further study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</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>Crossover Assignment</intervention_model>
      <intervention_model_description>analytical cross sectional</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis</measure>
      <time_frame>2 years</time_frame>
      <description>we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>bronchial wash group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained</description>
    </arm_group>
    <arm_group>
      <arm_group_label>bronchial brush</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>bronchoscope</intervention_name>
      <description>bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy</description>
      <arm_group_label>bronchial brush</arm_group_label>
      <arm_group_label>bronchial wash group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients in whom clinical findings, radiological examination suggested lung malignancy.&#xD;
          patients with chronic cough, hemoptysis and lymph node enlargement.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          patients with no evidence of malignancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>merna maged</last_name>
      <phone>+201284143158</phone>
      <email>mernamaged1@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>manal ahmed</last_name>
      <phone>+201009493236</phone>
    </overall_contact_backup>
    <reference>
      <citation>Hou G, Miao Y, Hu XJ, Wang W, Wang QY, Wu GP, Wang EH, Kang J. The optimal sequence for bronchial brushing and forceps biopsy in lung cancer diagnosis: a random control study. J Thorac Dis. 2016 Mar;8(3):520-6. doi: 10.21037/jtd.2016.02.12.</citation>
      <PMID>27076949</PMID>
    </reference>
    <reference>
      <citation>Lim JH, Kim MJ, Jeon SH, Park MH, Kim WY, Lee M, Kim JH, Kim JS, Kim YS, Kim L, Lee KH, Kwak SM, Shin H, Nam HS. The optimal sequence of bronchial brushing and washing for diagnosing peripheral lung cancer using non-guided flexible bronchoscopy. Sci Rep. 2020 Jan 23;10(1):1036. doi: 10.1038/s41598-020-58010-w.</citation>
      <PMID>31974454</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Merna Maged Monir</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </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>
  
  
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/NCT05992740
  org study id: bronchoscope in lung cancer
  nct id: NCT05992740
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study aims to compare the diagnostic yields of bronchial brushing performed before and
        after forceps biopsy and bronchial wash performed before and after biopsy during flexible
        bronchoscopy.
  Lung cancer is the most common cause of cancer-related mortality in both sexes in the world.
        To treat the disease successfully, it should be diagnosed at the earliest possible stage.
        Several studies have demonstrated that early detection, localization, and aggressive
        treatment of lung cancer result in the 5-year survival rate of 70-80%. Nowadays, bronchoscopy
        is an invaluable tool for diagnosis of lung cancer and various diagnostic tools have been
        developed using flexible fiber-optic bronchoscopy (FOB).
  
        Bronchoscopy, while essential for diagnosing and staging lung cancer, can give variable
        diagnostic yields ranging from37-77%. One reason for this variability is limitations in
        tissue sampling techniques, which can make it impossible to obtain the most representative
        area of neoplastic tissue. Numerous basic diagnostic procedures using FB, including
        bronchoalveolar lavage or washing, brushing, endobronchial or transbronchial biopsy(TBB), and
        transbronchial needle aspiration, have been evaluated in various combinations to improve the
        diagnostic yield of FB in patients with suspected lung cancer. However, the optimum sequence
        of brushing, washing and biopsy samples for diagnosing peripheral lung cancer is not clear
        and requires further study.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: analytical cross sectional
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: comparison between diagnostic yields of different tissue sampling techniques of bronchoscope in lung cancer diagnosis
  time frame: 2 years
  description: we will compare between the diagnostic yield of bronchial brushing group (pre-biopsy brushing + forceps biopsy + post-biopsy brushing) with the diagnostic yield of bronchial wash group (pre-biopsy bronchial wash + biopsy + post-biopsy bronchial wash).
  arm group label: bronchial wash group
  arm group type: Active Comparator
  description: the patients will undergo bronchoscope then pre-biopsy bronchial wash, biopsy, post-biopsy bronchial wash will be obtained
  arm group label: bronchial brush
  arm group type: Active Comparator
  description: the patients will undergo bronchoscope then pre-biopsy bronchial brush, biopsy, post-biopsy bronchial brush will be obtained
  intervention type: Device
  intervention name: bronchoscope
  description: bronchoscpe with broncial brush and biopsy or bronchial wash and biopsy
  arm group label: bronchial brush
  arm group label: bronchial wash group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: merna maged
  phone: +201284143158
  email: mernamaged1@gmail.com
  last name: manal ahmed
  phone: +201009493236
  citation: Hou G, Miao Y, Hu XJ, Wang W, Wang QY, Wu GP, Wang EH, Kang J. The optimal sequence for bronchial brushing and forceps biopsy in lung cancer diagnosis: a random control study. J Thorac Dis. 2016 Mar;8(3):520-6. doi: 10.21037/jtd.2016.02.12.
  PMID: 27076949
  citation: Lim JH, Kim MJ, Jeon SH, Park MH, Kim WY, Lee M, Kim JH, Kim JS, Kim YS, Kim L, Lee KH, Kwak SM, Shin H, Nam HS. The optimal sequence of bronchial brushing and washing for diagnosing peripheral lung cancer using non-guided flexible bronchoscopy. Sci Rep. 2020 Jan 23;10(1):1036. doi: 10.1038/s41598-020-58010-w.
  PMID: 31974454
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Merna Maged Monir
  investigator title: principal investigator
  mesh term: Lung Neoplasms