<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/NCT03261934</url>
  </required_header>
  <id_info>
    <org_study_id>81630080-CAG-REG</org_study_id>
    <nct_id>NCT03261934</nct_id>
  </id_info>
  <brief_title>Risk Assessment and Syndrome Evolution Models for Chronic Atrophic Gastritis Malignant Transformation</brief_title>
  <official_title>Risk Assessment and Syndrome Evolution Models Combining Traditional Chinese Medicine and Modern Medicine Indicators for Chronic Atrophic Gastritis Malignant Transformation: a Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing University of Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer&#xD;
      (GC). The present study aims to developed risk assessment and syndrome evolution models of&#xD;
      CAG malignant transformation events combining TCM indicators with modern medicine indicators.&#xD;
      The proposed study is a registry study based participant survey conducted in 4 hospitals in&#xD;
      Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed&#xD;
      with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and&#xD;
      off-site by telephone to track malignant transformation events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer&#xD;
      (GC). Active treatment of CAG is vital in arresting malignant transformation. Traditional&#xD;
      Chinese medicine (TCM) has been widely used in treating CAG and preventing GC. To date, no&#xD;
      study has been conducted to assess the risk and syndrome evolution features of CAG malignant&#xD;
      transformation by establishing models combining both TCM and modern medicine indicators.&#xD;
&#xD;
      The present study aims to developed risk assessment and syndrome evolution models of CAG&#xD;
      malignant transformation events combining TCM indicators with modern medicine indicators. The&#xD;
      proposed study is a registry study based participant survey conducted in 4 hospitals in&#xD;
      Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed&#xD;
      with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and&#xD;
      off-site by telephone to track malignant transformation events. Comparative analysis of&#xD;
      prevalence of malignant transformation events and presenting TCM or modern medicine features&#xD;
      in different groups is conducted using frequency analysis and chi-squared tests, and&#xD;
      expressed with composition ratios. Correlation analysis of malignant transformation events&#xD;
      and TCM or modern medicine factors will be performed using logistic regression, and&#xD;
      multivariate Cox proportional hazard model respectively. Exploratory factor analysis,&#xD;
      correspondence analysis, association rule analysis, hierarchical clustering analysis, and&#xD;
      complex system entropy clustering analysis will also be performed respectively for validating&#xD;
      features of syndrome evolution in CAG malignant transformation process.&#xD;
&#xD;
      Previous reports on modern medicine indicators based risk assessment model for ischemic&#xD;
      stroke endpoint events exist, but no studies have been undertaken combining TCM features. The&#xD;
      risk assessment model combining both TCM and modern medicine indicators has the potential to&#xD;
      facilitate early warning, early intervention and early control of CAG malignant&#xD;
      transformation. The syndrome evolution model will help evaluate the core TCM pathogenesis of&#xD;
      CAG malignant transformation so as to promote optimization of treatment strategies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>malignant transformation events of chronic atrophic gastritis</measure>
    <time_frame>10 years follow-up</time_frame>
    <description>The primary outcome measures will be the malignant transformation events of chronic atrophic gastritis, including gastric mucosal atrophy, intestinal metaplasia, gastric intraepithelial dysplasia, and gastric carcinoma, according to the definition given by &quot;Chronic Gastritis Diagnosis and Treatment Consensus of China (version 2012)&quot;, as promulgated by the Society of Gastroenterology, Chinese Medical Association.</description>
  </primary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Paraffin section of gastric mucosa&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This is a multicenter registry study conducted in 4 hopitals in Beijing, China, leaded by&#xD;
        Beijing University of Chinese Medicine. According to the inclusion and exclusion criteria,&#xD;
        2000 eligible participants will be identified by screening CAG patients after beginning the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) 18-75 years of age; (2) Meeting diagnostic criteria of CAG after upper gastrointestinal&#xD;
        endoscopy; (3) Willing to cooperate with data, tissue sample, and blood sample collection&#xD;
        during recruitment; (4) Willing to respond truthfully and timely to researcher queries&#xD;
        after recruitment, able to cooperate with data, tissue sample and blood sample collection&#xD;
        during follow-ups; (5) Willing to sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) Meeting past history of previous stomach surgery; (2) Unable to participate in data,&#xD;
        tissue sample or blood sample collection for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yin Zhang, MD</last_name>
    <phone>86-17710830835</phone>
    <email>coolzhangyin@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xia Ding, MD</last_name>
    <email>dingx@bucm.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dongzhimen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Li, Dr.</last_name>
      <phone>18801021127</phone>
    </contact>
    <investigator>
      <last_name>Yuan Li, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wangjing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100102</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping Zhang, Dr.</last_name>
    </contact>
    <contact_backup>
      <last_name>Ni Lou, Dr</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>December 25, 2020</last_update_submitted>
  <last_update_submitted_qc>December 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing University of Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Dr. Xia Ding</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Chronic Atrophic Gastritis</keyword>
  <keyword>Malignant Transformation</keyword>
  <keyword>Risk Assessment</keyword>
  <keyword>Syndrome Evolution</keyword>
  <keyword>Traditional Chinese Medicine</keyword>
  <keyword>Registry Study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastritis</mesh_term>
    <mesh_term>Gastritis, Atrophic</mesh_term>
    <mesh_term>Atrophy</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/NCT03261934
org study id: 81630080-CAG-REG
nct id: NCT03261934
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer
      (GC). The present study aims to developed risk assessment and syndrome evolution models of
      CAG malignant transformation events combining TCM indicators with modern medicine indicators.
      The proposed study is a registry study based participant survey conducted in 4 hospitals in
      Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed
      with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and
      off-site by telephone to track malignant transformation events.
Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer
      (GC). Active treatment of CAG is vital in arresting malignant transformation. Traditional
      Chinese medicine (TCM) has been widely used in treating CAG and preventing GC. To date, no
      study has been conducted to assess the risk and syndrome evolution features of CAG malignant
      transformation by establishing models combining both TCM and modern medicine indicators.

      The present study aims to developed risk assessment and syndrome evolution models of CAG
      malignant transformation events combining TCM indicators with modern medicine indicators. The
      proposed study is a registry study based participant survey conducted in 4 hospitals in
      Beijing, China. After obtaining informed consent, a total of 2000 study patients diagnosed
      with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and
      off-site by telephone to track malignant transformation events. Comparative analysis of
      prevalence of malignant transformation events and presenting TCM or modern medicine features
      in different groups is conducted using frequency analysis and chi-squared tests, and
      expressed with composition ratios. Correlation analysis of malignant transformation events
      and TCM or modern medicine factors will be performed using logistic regression, and
      multivariate Cox proportional hazard model respectively. Exploratory factor analysis,
      correspondence analysis, association rule analysis, hierarchical clustering analysis, and
      complex system entropy clustering analysis will also be performed respectively for validating
      features of syndrome evolution in CAG malignant transformation process.

      Previous reports on modern medicine indicators based risk assessment model for ischemic
      stroke endpoint events exist, but no studies have been undertaken combining TCM features. The
      risk assessment model combining both TCM and modern medicine indicators has the potential to
      facilitate early warning, early intervention and early control of CAG malignant
      transformation. The syndrome evolution model will help evaluate the core TCM pathogenesis of
      CAG malignant transformation so as to promote optimization of treatment strategies.
observational model: Other
time perspective: Prospective
measure: malignant transformation events of chronic atrophic gastritis
time frame: 10 years follow-up
description: The primary outcome measures will be the malignant transformation events of chronic atrophic gastritis, including gastric mucosal atrophy, intestinal metaplasia, gastric intraepithelial dysplasia, and gastric carcinoma, according to the definition given by "Chronic Gastritis Diagnosis and Treatment Consensus of China (version 2012)", as promulgated by the Society of Gastroenterology, Chinese Medical Association.
intervention type: Other
intervention name: No intervention
description: No intervention
Paraffin section of gastric mucosa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yin Zhang, MD
phone: 86-17710830835
email: coolzhangyin@sina.com
last name: Xia Ding, MD
email: dingx@bucm.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing University of Chinese Medicine
investigator full name: Dr. Xia Ding
investigator title: Professor
mesh term: Gastritis
mesh term: Gastritis, Atrophic
mesh term: Atrophy
sharing ipd: No