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/NCT06039917</url>
    </required_header>
    <id_info>
      <org_study_id>EA-AS2023-01</org_study_id>
      <nct_id>NCT06039917</nct_id>
    </id_info>
    <brief_title>Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions</brief_title>
    <official_title>Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Renmin Hospital of Wuhan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Pudong Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Renmin Hospital of Wuhan 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>
        In this study, we proposed a prospective study about the effect of the automatic surveillance&#xD;
        system on surveillance rate of patients with gastric premalignant lesions. The enrolled&#xD;
        patients were divided into group A with intelligent surveillance system, group B with manual&#xD;
        reminder, and group C with natural state. The surveillance among the three groups will be&#xD;
        compared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The adherence of doctors to published surveillance guidelines for patients with gastric&#xD;
        premalignant lesions varies greatly, and surveillance of patients is critical but&#xD;
        time-consuming. In previous studies we developed an automatic surveillance (AS) system to&#xD;
        accurately identify patients with gastric premalignant lesions, assign surveillance intervals&#xD;
        for different risks of patients and proactively follow up with patients in time. In this&#xD;
        study, we proposed a prospective study about the effect of the automatic surveillance system&#xD;
        on surveillance rate of patients with gastric premalignant lesions. The enrolled patients&#xD;
        were divided into group A with intelligent surveillance system, group B with manual reminder,&#xD;
        and group C with natural state. The surveillance among the three groups will be compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>Screening</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>On-time Surveillance Rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surveillance Rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Advance Surveillance Rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with surveillance in advance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delayed Surveillance Rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with delayed surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The accuracy of identifying patients with gastric premalignant lesions</measure>
      <time_frame>1 day At the time of enrollment</time_frame>
      <description>The numerator is the number of patients correctly identified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The accuracy of classifying risk levels</measure>
      <time_frame>1 day At the time of enrollment</time_frame>
      <description>The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The accuracy of assigning surveillance intervals</measure>
      <time_frame>1 day At the time of enrollment</time_frame>
      <description>The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lesion progression rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with lesion progression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lesion persistence rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with lesion persistence, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lesion regression rate</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with lesion regression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence rate of early gastric cancer</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with early gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence rate of gastric cancer</measure>
      <time_frame>From enrollment to study completion, assessed up to 3 years.</time_frame>
      <description>The numerator is the number of patients with gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1460</enrollment>
    <condition>Artificial Intelligence</condition>
    <condition>Surveillance</condition>
    <arm_group>
      <arm_group_label>With automatic surveillance system</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>With manual reminder</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AI based automatic surveillance (AS) system (ENDOANGEL-AS)</intervention_name>
      <description>An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.</description>
      <arm_group_label>With automatic surveillance system</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Manually remind the patients</intervention_name>
      <description>Medical staff remind patients to review manually.</description>
      <arm_group_label>With manual reminder</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female aged 18 years or older who undergo upper endoscopy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1)No contact information or invalid contact information.&#xD;
  &#xD;
            -  2) The surveillance interval cannot be determined according to the surveillance&#xD;
               guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or&#xD;
               with history of previous gastrectomy, esophagectomy, or ESD, no dysplasia degrees, no&#xD;
               biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on.&#xD;
  &#xD;
            -  3) Needless for surveillance or others.&#xD;
  &#xD;
            -  4) High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.&#xD;
  &#xD;
            -  5) Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.&#xD;
  &#xD;
            -  6) High-risk diseases or other special conditions for which the patient is deemed&#xD;
               unsuitable for clinical trials by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Honggang Yu, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Renmin Hospital of Wuhan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Honggang Yu, PhD</last_name>
      <phone>13871281899</phone>
      <email>yuhonggang1969@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Renmin Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430060</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Honggang Yu, PhD</last_name>
        <phone>13871281899</phone>
        <email>yuhonggang@whu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Pudong Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>201399</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wujun Xiong, Doctor</last_name>
        <phone>13916617586</phone>
        <email>xiongwujun@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>surveillance rate</keyword>
    <keyword>automatic surveillance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Precancerous Conditions</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06039917
  org study id: EA-AS2023-01
  nct id: NCT06039917
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, we proposed a prospective study about the effect of the automatic surveillance
        system on surveillance rate of patients with gastric premalignant lesions. The enrolled
        patients were divided into group A with intelligent surveillance system, group B with manual
        reminder, and group C with natural state. The surveillance among the three groups will be
        compared.
  The adherence of doctors to published surveillance guidelines for patients with gastric
        premalignant lesions varies greatly, and surveillance of patients is critical but
        time-consuming. In previous studies we developed an automatic surveillance (AS) system to
        accurately identify patients with gastric premalignant lesions, assign surveillance intervals
        for different risks of patients and proactively follow up with patients in time. In this
        study, we proposed a prospective study about the effect of the automatic surveillance system
        on surveillance rate of patients with gastric premalignant lesions. The enrolled patients
        were divided into group A with intelligent surveillance system, group B with manual reminder,
        and group C with natural state. The surveillance among the three groups will be compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Screening
  masking: Double (Participant, Care Provider)
  measure: On-time Surveillance Rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
  measure: Surveillance Rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
  measure: Advance Surveillance Rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with surveillance in advance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
  measure: Delayed Surveillance Rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with delayed surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
  measure: The accuracy of identifying patients with gastric premalignant lesions
  time frame: 1 day At the time of enrollment
  description: The numerator is the number of patients correctly identified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.
  measure: The accuracy of classifying risk levels
  time frame: 1 day At the time of enrollment
  description: The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.
  measure: The accuracy of assigning surveillance intervals
  time frame: 1 day At the time of enrollment
  description: The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.
  measure: lesion progression rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with lesion progression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
  measure: lesion persistence rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with lesion persistence, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
  measure: lesion regression rate
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with lesion regression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
  measure: The incidence rate of early gastric cancer
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with early gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
  measure: The incidence rate of gastric cancer
  time frame: From enrollment to study completion, assessed up to 3 years.
  description: The numerator is the number of patients with gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.
  arm group label: With automatic surveillance system
  arm group type: Experimental
  description: Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time.
  arm group label: With manual reminder
  arm group type: Experimental
  description: Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.
  arm group label: Normal group
  arm group type: No Intervention
  description: The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
  intervention type: Other
  intervention name: AI based automatic surveillance (AS) system (ENDOANGEL-AS)
  description: An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.
  arm group label: With automatic surveillance system
  intervention type: Other
  intervention name: Manually remind the patients
  description: Medical staff remind patients to review manually.
  arm group label: With manual reminder
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Honggang Yu, PhD
  role: Principal Investigator
  affiliation: Renmin Hospital of Wuhan University
  last name: Honggang Yu, PhD
  phone: 13871281899
  email: yuhonggang1969@163.com
  facility: 
  contact: 
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Precancerous Conditions
  sharing ipd: No