<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/NCT04413669</url>
  </required_header>
  <id_info>
    <org_study_id>SHCHE201907</org_study_id>
    <nct_id>NCT04413669</nct_id>
  </id_info>
  <brief_title>Bronchoscopy Screening for High-risk Population of Lung Cancer With Severe Smoking With Negative LDCT Screen</brief_title>
  <official_title>Bronchoscopy Screening of High-risk Population of Lung Cancer With Severe Smoking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiayuan Sun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Chest Hospital</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>
      Based on the previous work of LDCT screening, in order to improve the screening rate of&#xD;
      central lung cancer for LDCT negative and severe smokers, the investigators plan to conduct&#xD;
      China's first large-scale fluorescent bronchoscopy screening test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CT scan is a commonly used method for clinical screening for early lung cancer, but research&#xD;
      shows that LDCT scan has a higher detection rate for peripheral lesions (often&#xD;
      adenocarcinoma), and a lower detection rate for central lung cancer (mostly squamous cell&#xD;
      carcinoma). Fluorescent bronchoscopy uses the principle of differentiating fluorescence in&#xD;
      different tissues to distinguish normal parts from diseased parts. It is often used for&#xD;
      screening of central early lung cancer.Based on the results of the investigator's previous&#xD;
      research, the investigators plan to conduct a second round of community&#xD;
      screening-bronchoscopy screening, and perform white light bronchoscopy and autofluorescence&#xD;
      bronchoscopy screening for high-risk groups of lung cancer with heavy smoking (≥400 years)&#xD;
      and no obvious lung nodules.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of AFB and WLB screening （the positive rate of lung cancer）on LDCT screening negative at high risk for lung cancer was analyzed.</measure>
    <time_frame>one year</time_frame>
    <description>ALB and WLB were screened for LDCT screening for lung cancer negative severe smokers. The effect of AFB and WLB screening on LDCT screening negative lung cancer at high risk was analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The diagnostic efficacy of WLB and AFB in lung cancer was compared</measure>
    <time_frame>one year</time_frame>
    <description>The diagnostic efficacy of WLB and AFB in lung cancer was compared by comparing abnormalities under WLB and AFB and histopathology respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The independent risk factors of lung cancer in high-risk groups were Identified.</measure>
    <time_frame>one year</time_frame>
    <description>Univariate and multivariate Logistic regression analysis was carried out to screen the independent risk factors of lung cancer in high-risk groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RGB（red-green-blue） chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.</measure>
    <time_frame>one year</time_frame>
    <description>RGB（red-green-blue） chrominance spatial differences of AFB in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.</measure>
    <time_frame>one year</time_frame>
    <description>Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Heavy Smoking</condition>
  <arm_group>
    <arm_group_label>white light bronchoscopy and autofluorescence bronchoscopy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>White light bronchoscopy and autofluorescence bronchoscopy were carried out for people at high risk for lung cancer with heavy smoking (smoking history&gt; 400 years).Biopsy was taken for abnormal bronchial mucosa.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>white light bronchoscopy &amp; autofluorescence bronchoscopy</intervention_name>
    <description>White light bronchoscopy and autofluorescence bronchoscopy were carried out，and Take a biopsy for abnormal bronchial mucosa</description>
    <arm_group_label>white light bronchoscopy and autofluorescence bronchoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 45-75 years;&#xD;
&#xD;
          2. have a smoking history of ≥20 pack years; if participants quit smoking, it should be&#xD;
             &lt;15 years;&#xD;
&#xD;
          3. Chest LDCT examination within one and a half years without obvious abnormalities or&#xD;
             calcified nodules or non-calcified nodules and no signs of malignancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-smokers or mild smokers;&#xD;
&#xD;
          2. There are contraindications to bronchoscopy, such as active hemoptysis, unstable&#xD;
             angina pectoris, coagulation dysfunction, anesthesia allergy, etc .;&#xD;
&#xD;
          3. Refusing to sign informed consent;&#xD;
&#xD;
          4. The operator believes that the patient has other conditions that are not suitable for&#xD;
             bronchoscopy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiayuan Sun, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiayuan Sun, PhD</last_name>
    <phone>86-021-22200000</phone>
    <phone_ext>1511</phone_ext>
    <email>jysun1976@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jiayuan Sun, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiayuan Sun, PhD</last_name>
      <phone>+86-021-22200000</phone>
      <phone_ext>1511</phone_ext>
      <email>jysun1976@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 3, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Jiayuan Sun</investigator_full_name>
    <investigator_title>Director, Department of Endoscopy, Shanghai Chest Hospital</investigator_title>
  </responsible_party>
  <keyword>Heavy smoking</keyword>
  <keyword>People at high risk for lung cancer</keyword>
  <keyword>autofluorescence bronchoscopy，AFB</keyword>
  <keyword>white light bronchoscopy, WLB</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</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/NCT04413669
org study id: SHCHE201907
nct id: NCT04413669
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Based on the previous work of LDCT screening, in order to improve the screening rate of
      central lung cancer for LDCT negative and severe smokers, the investigators plan to conduct
      China's first large-scale fluorescent bronchoscopy screening test.
CT scan is a commonly used method for clinical screening for early lung cancer, but research
      shows that LDCT scan has a higher detection rate for peripheral lesions (often
      adenocarcinoma), and a lower detection rate for central lung cancer (mostly squamous cell
      carcinoma). Fluorescent bronchoscopy uses the principle of differentiating fluorescence in
      different tissues to distinguish normal parts from diseased parts. It is often used for
      screening of central early lung cancer.Based on the results of the investigator's previous
      research, the investigators plan to conduct a second round of community
      screening-bronchoscopy screening, and perform white light bronchoscopy and autofluorescence
      bronchoscopy screening for high-risk groups of lung cancer with heavy smoking (≥400 years)
      and no obvious lung nodules.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The effect of AFB and WLB screening （the positive rate of lung cancer）on LDCT screening negative at high risk for lung cancer was analyzed.
time frame: one year
description: ALB and WLB were screened for LDCT screening for lung cancer negative severe smokers. The effect of AFB and WLB screening on LDCT screening negative lung cancer at high risk was analyzed.
measure: The diagnostic efficacy of WLB and AFB in lung cancer was compared
time frame: one year
description: The diagnostic efficacy of WLB and AFB in lung cancer was compared by comparing abnormalities under WLB and AFB and histopathology respectively.
measure: The independent risk factors of lung cancer in high-risk groups were Identified.
time frame: one year
description: Univariate and multivariate Logistic regression analysis was carried out to screen the independent risk factors of lung cancer in high-risk groups.
measure: RGB（red-green-blue） chrominance spatial differences in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.
time frame: one year
description: RGB（red-green-blue） chrominance spatial differences of AFB in normal sites, low-grade preinvasive (LGD), high-grade intraepithelial neoplasia, and invasive cancer was analyzed.
measure: Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.
time frame: one year
description: Blood was drawn for liquid molecular detection to identify the molecular markers associated with lung cancer.
arm group label: white light bronchoscopy and autofluorescence bronchoscopy
arm group type: Experimental
description: White light bronchoscopy and autofluorescence bronchoscopy were carried out for people at high risk for lung cancer with heavy smoking (smoking history> 400 years).Biopsy was taken for abnormal bronchial mucosa.
intervention type: Procedure
intervention name: white light bronchoscopy & autofluorescence bronchoscopy
description: White light bronchoscopy and autofluorescence bronchoscopy were carried out，and Take a biopsy for abnormal bronchial mucosa
arm group label: white light bronchoscopy and autofluorescence bronchoscopy
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiayuan Sun, PhD
role: Study Director
affiliation: Shanghai Chest Hospital
last name: Jiayuan Sun, PhD
phone: 86-021-22200000
phone ext: 1511
email: jysun1976@163.com
last name: Jiayuan Sun, MD
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Jiayuan Sun
investigator title: Director, Department of Endoscopy, Shanghai Chest Hospital
mesh term: Lung Neoplasms
sharing ipd: No