<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/NCT02968069</url>
  </required_header>
  <id_info>
    <org_study_id>2016-138k</org_study_id>
    <nct_id>NCT02968069</nct_id>
  </id_info>
  <brief_title>A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions</brief_title>
  <official_title>Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Putuo district Liqun hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai MCC worker hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic&#xD;
      efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community&#xD;
      hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous&#xD;
      lesions.The investigators will conduct a study to develop and validate a diagnostic model&#xD;
      based on NBI for early gastric cancerous lesions under endoscopic observation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for&#xD;
      histological diagnosis of gastric epithelial neoplasia before proper management.Many studies&#xD;
      have shown that there exist considerable discrepancies between EFB and subsequently resected&#xD;
      specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic&#xD;
      efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community&#xD;
      hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be&#xD;
      observed. Here, the investigators will conduct a study to develop and validate a diagnostic&#xD;
      model based on narrow band imaging for early gastric cancerous lesions under endoscopic&#xD;
      observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Suspected gastric cancerous lesions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnifying endoscopy with NBI would be conducted for every patient included in our study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NBI</intervention_name>
    <description>Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.</description>
    <arm_group_label>Suspected gastric cancerous lesions</arm_group_label>
    <other_name>Evis Lucera system (CV-260, Olympus Inc, Japan)</other_name>
    <other_name>high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan)</other_name>
    <other_name>magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suspected of having a cancerous lesions&#xD;
&#xD;
          -  The age of patients is from 40-80 years&#xD;
&#xD;
          -  Patients must undergo esophagogastroduodenoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of advanced gastric cancer&#xD;
&#xD;
          -  Acute upper gastrointestinal bleeding&#xD;
&#xD;
          -  Severe systemic diseases&#xD;
&#xD;
          -  Refuse to attend the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaobo Li, MD.Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaobo Li, MD.Ph.D</last_name>
    <phone>86-21-58752345</phone>
    <email>lxb_1969@163.com</email>
  </overall_contact>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Xiaobo Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach 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/NCT02968069
org study id: 2016-138k
nct id: NCT02968069
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic
      efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community
      hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous
      lesions.The investigators will conduct a study to develop and validate a diagnostic model
      based on NBI for early gastric cancerous lesions under endoscopic observation.
Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for
      histological diagnosis of gastric epithelial neoplasia before proper management.Many studies
      have shown that there exist considerable discrepancies between EFB and subsequently resected
      specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic
      efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community
      hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be
      observed. Here, the investigators will conduct a study to develop and validate a diagnostic
      model based on narrow band imaging for early gastric cancerous lesions under endoscopic
      observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions
time frame: 36 months
arm group label: Suspected gastric cancerous lesions
arm group type: Experimental
description: Magnifying endoscopy with NBI would be conducted for every patient included in our study
intervention type: Device
intervention name: NBI
description: Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.
arm group label: Suspected gastric cancerous lesions
other name: Evis Lucera system (CV-260, Olympus Inc, Japan)
other name: high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan)
other name: magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaobo Li, MD.Ph.D
role: Principal Investigator
affiliation: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai
last name: Xiaobo Li, MD.Ph.D
phone: 86-21-58752345
email: lxb_1969@163.com
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Xiaobo Li
investigator title: Professor
mesh term: Stomach Neoplasms
sharing ipd: No