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/NCT05979935</url>
    </required_header>
    <id_info>
      <org_study_id>20230726-QiluH</org_study_id>
      <nct_id>NCT05979935</nct_id>
    </id_info>
    <brief_title>Prediction of Esophageal Varices in Liver Cirrhosis Using Tongue Bioinformatics</brief_title>
    <official_title>A Study on Predicting Esophageal Varices in Liver Cirrhosis Using Tongue Bioinformatics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jinan Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qianfoshan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Qilu Hospital of Shandong 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 goal of this observational study is to compare the tongue bioinformatics of high-risk and&#xD;
        low-risk patients with esophageal varices due to liver cirrhosis.&#xD;
  &#xD;
        The main question of this study is to explore whether there exists a relationship between the&#xD;
        degree of esophageal varices and tongue bioinformatics in liver cirrhosis. it aims to answer&#xD;
        2 questions as below:&#xD;
  &#xD;
        question 1: If these is a significant difference in tongue bioinformatics between patients in&#xD;
        liver cirrhosis with high-risk and low-risk of esophageal varices.&#xD;
  &#xD;
        Question 2; If tongue bioinformatics can be used as a diagnostic basic for testing esophageal&#xD;
        varices in liver cirrhosis.&#xD;
  &#xD;
        Firstly, participants will be divided into two groups according to their degree of esophageal&#xD;
        varices from electronic gastroscopy report and CT scan report including high-risk group and&#xD;
        low-risk group. Secondly, participants will be asked to show their tongue, including the&#xD;
        surface and sublingual veins of tongue, and the tongue images of each participants will be&#xD;
        collected by researchers via camera. After finishing tongue image collection, participants&#xD;
        will receive a professional tongue diagnosis report in Traditional Chinese Medicine and&#xD;
        health suggestion.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Esophageal varices is diagnosed by electronic gastroscopy</measure>
      <time_frame>6 months</time_frame>
      <description>Electronic gastroscopy is a standard method to diagnosis esophageal varices for patients with cirrhosis. Especially, the electronic gastroscopy can detect the degree of esophageal varices detallly, including the diameter and red sign of varices veins.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tongue images analysis by artificial intelligence</measure>
      <time_frame>6 months</time_frame>
      <description>Tongue images of participants will be analyzed by using artificial intelligence technology. And the result will be used to test If tongue bioinformatics is related to the degree of esophageal varices in liver cirrhosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Specific Characteristic in Tongue Bioinformatics</measure>
      <time_frame>6 months</time_frame>
      <description>Artificial intelligence technology and statistic analysis will be used to study the specific difference in tongue bioinformatics between high-risk and low-risk group esophageal varices in patients with liver cirrhosis.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Esophageal and Gastric Varices</condition>
    <arm_group>
      <arm_group_label>patients with high-risk of esophageal varices in liver cirrhosis</arm_group_label>
      <description>The diameter of varices vein is over 0.5cm with red sign in patients with esophageal varices due to liver cirrhosis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patients with low-risk of esophageal varices in liver cirrhosis</arm_group_label>
      <description>The diameter of varices vein is below 0.5cm with negative red sign in patients with esophageal varices due to liver cirrhosis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>tongue diagnosis</intervention_name>
      <description>The tongue image of participants will be collected via camera and professional tongue diagnosis report will be provided to pariticipants.</description>
      <arm_group_label>patients with high-risk of esophageal varices in liver cirrhosis</arm_group_label>
      <arm_group_label>patients with low-risk of esophageal varices in liver cirrhosis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study subjects are patients with liver cirrhosis from the Department of&#xD;
          Gastroenterology, Qilu Hospital, Shandong University, the Department of Hepatology, Qianfo&#xD;
          Mountain Hospital of Shandong Province, and the Department of Gastroenterology, Jinan&#xD;
          Central Hospital. According to the 《Prevention and Treatment Plan for Viral Hepatitis》&#xD;
          revised by the Infectious Diseases and Parasitic disease Branch and Hepatology Branch of&#xD;
          the Chinese Medical Association in September 2000, Patients with liver cirrhosis and&#xD;
          esophageal varices aged 18-75 years will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with liver cirrhosis has been diagnosed according to clinical manifestations,&#xD;
               blood test and imaging examination.&#xD;
  &#xD;
            2. Patients with abdominal enhanced CT scans and upper gastrointestinal endoscopy,&#xD;
  &#xD;
            3. Patients who have signed informed consent forms.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient who has previously received endoscopic treatment, transjugular intrahepatic&#xD;
               portosystemic shunt (TIPS), splenectomy, Hepatectomy, balloon occlusion of retrograde&#xD;
               veins or liver transplantation.&#xD;
  &#xD;
            2. Severe ascites or Hepatic encephalopathy is painted.&#xD;
  &#xD;
            3. Patient with concurrent primary liver cancer;&#xD;
  &#xD;
            4. Concurrent severe infection of other systems;&#xD;
  &#xD;
            5. Symptoms of liver cirrhosis subside after antiviral treatment;&#xD;
  &#xD;
            6. Patient who is taking beta receptor blockers;&#xD;
  &#xD;
            7. Paitent with mental disorders;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Yanjing Gao, PhD MD</last_name>
      <role>Study Chair</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Qilu Hospital of Shdong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Ou J, Li R, Zeng R, Wu CQ, Chen Y, Chen TW, Zhang XM, Wu L, Jiang Y, Yang JQ, Cao JM, Tang S, Tang MJ, Hu J. CT radiomic features for predicting resectability of oesophageal squamous cell carcinoma as given by feature analysis: a case control study. Cancer Imaging. 2019 Oct 16;19(1):66. doi: 10.1186/s40644-019-0254-0.</citation>
      <PMID>31619297</PMID>
    </results_reference>
    <results_reference>
      <citation>Tandon M, Singh H, Singla N, Jain P, Pandey CK. Tongue thickness in health vs cirrhosis of the liver: Prospective observational study. World J Gastrointest Pharmacol Ther. 2020 Aug 8;11(3):59-68. doi: 10.4292/wjgpt.v11.i3.59.</citation>
      <PMID>32844044</PMID>
    </results_reference>
    <results_reference>
      <citation>He C, Liao Q, Fu P, Li J, Zhao X, Zhang Q, Gui Q. Microbiological characteristics of different tongue coatings in adults. BMC Microbiol. 2022 Sep 9;22(1):214. doi: 10.1186/s12866-022-02626-7.</citation>
      <PMID>36085010</PMID>
    </results_reference>
    <results_reference>
      <citation>Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.</citation>
      <PMID>34115257</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>tongue bioinformatics, esophageal and gastric varices</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Esophageal and Gastric Varices</mesh_term>
      <mesh_term>Varicose Veins</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/NCT05979935
  org study id: 20230726-QiluH
  nct id: NCT05979935
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare the tongue bioinformatics of high-risk and
        low-risk patients with esophageal varices due to liver cirrhosis.
  
        The main question of this study is to explore whether there exists a relationship between the
        degree of esophageal varices and tongue bioinformatics in liver cirrhosis. it aims to answer
        2 questions as below:
  
        question 1: If these is a significant difference in tongue bioinformatics between patients in
        liver cirrhosis with high-risk and low-risk of esophageal varices.
  
        Question 2; If tongue bioinformatics can be used as a diagnostic basic for testing esophageal
        varices in liver cirrhosis.
  
        Firstly, participants will be divided into two groups according to their degree of esophageal
        varices from electronic gastroscopy report and CT scan report including high-risk group and
        low-risk group. Secondly, participants will be asked to show their tongue, including the
        surface and sublingual veins of tongue, and the tongue images of each participants will be
        collected by researchers via camera. After finishing tongue image collection, participants
        will receive a professional tongue diagnosis report in Traditional Chinese Medicine and
        health suggestion.
  observational model: Case-Control
  time perspective: Prospective
  measure: Esophageal varices is diagnosed by electronic gastroscopy
  time frame: 6 months
  description: Electronic gastroscopy is a standard method to diagnosis esophageal varices for patients with cirrhosis. Especially, the electronic gastroscopy can detect the degree of esophageal varices detallly, including the diameter and red sign of varices veins.
  measure: Tongue images analysis by artificial intelligence
  time frame: 6 months
  description: Tongue images of participants will be analyzed by using artificial intelligence technology. And the result will be used to test If tongue bioinformatics is related to the degree of esophageal varices in liver cirrhosis.
  measure: Specific Characteristic in Tongue Bioinformatics
  time frame: 6 months
  description: Artificial intelligence technology and statistic analysis will be used to study the specific difference in tongue bioinformatics between high-risk and low-risk group esophageal varices in patients with liver cirrhosis.
  arm group label: patients with high-risk of esophageal varices in liver cirrhosis
  description: The diameter of varices vein is over 0.5cm with red sign in patients with esophageal varices due to liver cirrhosis.
  arm group label: patients with low-risk of esophageal varices in liver cirrhosis
  description: The diameter of varices vein is below 0.5cm with negative red sign in patients with esophageal varices due to liver cirrhosis.
  intervention type: Diagnostic Test
  intervention name: tongue diagnosis
  description: The tongue image of participants will be collected via camera and professional tongue diagnosis report will be provided to pariticipants.
  arm group label: patients with high-risk of esophageal varices in liver cirrhosis
  arm group label: patients with low-risk of esophageal varices in liver cirrhosis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Yanjing Gao, PhD MD
  role: Study Chair
  affiliation: Qilu Hospital of Shandong University
  facility: 
  country: China
  citation: Ou J, Li R, Zeng R, Wu CQ, Chen Y, Chen TW, Zhang XM, Wu L, Jiang Y, Yang JQ, Cao JM, Tang S, Tang MJ, Hu J. CT radiomic features for predicting resectability of oesophageal squamous cell carcinoma as given by feature analysis: a case control study. Cancer Imaging. 2019 Oct 16;19(1):66. doi: 10.1186/s40644-019-0254-0.
  PMID: 31619297
  citation: Tandon M, Singh H, Singla N, Jain P, Pandey CK. Tongue thickness in health vs cirrhosis of the liver: Prospective observational study. World J Gastrointest Pharmacol Ther. 2020 Aug 8;11(3):59-68. doi: 10.4292/wjgpt.v11.i3.59.
  PMID: 32844044
  citation: He C, Liao Q, Fu P, Li J, Zhao X, Zhang Q, Gui Q. Microbiological characteristics of different tongue coatings in adults. BMC Microbiol. 2022 Sep 9;22(1):214. doi: 10.1186/s12866-022-02626-7.
  PMID: 36085010
  citation: Lin Y, Li L, Yu D, Liu Z, Zhang S, Wang Q, Li Y, Cheng B, Qiao J, Gao Y. A novel radiomics-platelet nomogram for the prediction of gastroesophageal varices needing treatment in cirrhotic patients. Hepatol Int. 2021 Aug;15(4):995-1005. doi: 10.1007/s12072-021-10208-4. Epub 2021 Jun 11.
  PMID: 34115257
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Esophageal and Gastric Varices
  mesh term: Varicose Veins
  sharing ipd: No