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/NCT05996458</url>
    </required_header>
    <id_info>
      <org_study_id>KY20232111-F-1号</org_study_id>
      <nct_id>NCT05996458</nct_id>
    </id_info>
    <brief_title>A Population-based, Multicenter Cohort Study of Combined Screening for Gastrointestinal Tumors</brief_title>
    <official_title>A Population-based, Multicenter Cohort Study of Combined Screening for Gastrointestinal Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing 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>
        To establish combined gastroenteroscopy screening and follow-up management for&#xD;
        gastrointestinal tumors, explore and evaluate the feasibility and health economic benefits of&#xD;
        combined screening for esophagus, stomach and colorectal cancer&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood&#xD;
        test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180) and&#xD;
        SEPTIN9 gene methylation test, and investigation of risk factors, including past disease&#xD;
        history, alcohol drinking history, smoking history, tea drinking history, family history of&#xD;
        cancer, marital and reproductive status, and dietary habits.&#xD;
  &#xD;
        group two: The screening population will undergo investigation of risk factors, a fecal&#xD;
        occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool&#xD;
        occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene&#xD;
        methylation testing will be scheduled. If the gene methylation test is positive, a&#xD;
        colonoscopy will be scheduled.&#xD;
  &#xD;
        Group one's control（Spouse or sibling of group one);group two's control（Spouse or sibling of&#xD;
        group one): Only the risk factors will be investigated, including previous disease history,&#xD;
        drinking history, smoking history, drinking history, family history of malignant tumor,&#xD;
        marriage and childbearing status, eating habits, etc.&#xD;
  &#xD;
        Finally, 10 years follow-up will be conducted to observe the outcome&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2033</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2032</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Cancer or precancerous lesions detected</measure>
      <time_frame>10 year</time_frame>
      <description>Cancer or precancerous lesions detected</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">84000</enrollment>
    <condition>Digestive Disease</condition>
    <arm_group>
      <arm_group_label>group one</arm_group_label>
      <description>The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180) and SEPTIN9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group one's control（Spouse or sibling of group one )</arm_group_label>
      <description>Only the risk factors will be investigated</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group two</arm_group_label>
      <description>The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group two's control（Spouse or sibling of group two)</arm_group_label>
      <description>Only the risk factors will be investigated</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test</intervention_name>
      <description>group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, RNF180/Septin9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.</description>
      <arm_group_label>group one</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Risk factor investigation;</intervention_name>
      <description>Only the risk factors will be investigated, including previous disease history, drinking history, smoking history, drinking history, family history of malignant tumor, marriage and childbearing status, eating habits, etc.</description>
      <arm_group_label>Group one's control（Spouse or sibling of group one )</arm_group_label>
      <arm_group_label>group two's control（Spouse or sibling of group two)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test</intervention_name>
      <description>group two: The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.</description>
      <arm_group_label>group two</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood；tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Eligible Chinese persons&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Subjects were 45 to 70 years old when enrolled 2. Willing and able to sign informed&#xD;
               consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. History of any type of malignancy 2. Previous resection of esophagus, stomach or&#xD;
               colorectal 3. Received gastrointestinal endoscopy such as colonoscopy and gastroscopy&#xD;
               in recent 5 years 4. Have received fecal occult blood test and fecal DNA test in the&#xD;
               past 1 year. 5. Contraindications to endoscopy. 6. Warning symptoms of digestive tract&#xD;
               tumors, including:&#xD;
  &#xD;
                 1. Difficulty swallowing, choking or halting feeling when eating recently&#xD;
  &#xD;
                 2. Recent esophageal foreign body sensation or swallowing pain&#xD;
  &#xD;
                 3. Recent long-term loss of appetite and appetite&#xD;
  &#xD;
                 4. Recent and prolonged symptoms of indigestion (including acid reflux, heartburn,&#xD;
                    abdominal grumbling, burping, nausea or premature satiety, etc.)&#xD;
  &#xD;
                 5. Recent symptoms of abdominal mass, abdominal pain, vomiting or hematemesis&#xD;
  &#xD;
                 6. It was medically diagnosed as iron deficiency anemia&#xD;
  &#xD;
                 7. Recent changes in hematochezia, black stool or stool character and frequency&#xD;
  &#xD;
                 8. Recent symptoms of perianal discomfort (including soreness, itching, lumps,&#xD;
                    prolapse or other discomfort)&#xD;
  &#xD;
                 9. Unexplained weight loss (more than 10% of base body weight) in the past 6 months&#xD;
                    Step 7 Get pregnant 8. There are other serious comorbiditions that reduce&#xD;
                    screening benefits (including severe lung disease, advanced kidney disease,&#xD;
                    advanced liver disease, severe heart failure, etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kaichun Wu</last_name>
      <role>Study Chair</role>
      <affiliation>Xijing Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>rong zheng</last_name>
      <phone>19829758242</phone>
      <email>zhengrong4956@163.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Digestive System Neoplasms</mesh_term>
      <mesh_term>Gastrointestinal Neoplasms</mesh_term>
      <mesh_term>Digestive System Diseases</mesh_term>
      <mesh_term>Gastrointestinal Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>According to the research process, choose a specific method to disclose the original data.</ipd_description>
    </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/NCT05996458
  org study id: KY20232111-F-1号
  nct id: NCT05996458
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To establish combined gastroenteroscopy screening and follow-up management for
        gastrointestinal tumors, explore and evaluate the feasibility and health economic benefits of
        combined screening for esophagus, stomach and colorectal cancer
  group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood
        test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180) and
        SEPTIN9 gene methylation test, and investigation of risk factors, including past disease
        history, alcohol drinking history, smoking history, tea drinking history, family history of
        cancer, marital and reproductive status, and dietary habits.
  
        group two: The screening population will undergo investigation of risk factors, a fecal
        occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool
        occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene
        methylation testing will be scheduled. If the gene methylation test is positive, a
        colonoscopy will be scheduled.
  
        Group one's control（Spouse or sibling of group one);group two's control（Spouse or sibling of
        group one): Only the risk factors will be investigated, including previous disease history,
        drinking history, smoking history, drinking history, family history of malignant tumor,
        marriage and childbearing status, eating habits, etc.
  
        Finally, 10 years follow-up will be conducted to observe the outcome
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Cancer or precancerous lesions detected
  time frame: 10 year
  description: Cancer or precancerous lesions detected
  arm group label: group one
  description: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180) and SEPTIN9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.
  arm group label: Group one's control（Spouse or sibling of group one )
  description: Only the risk factors will be investigated
  arm group label: group two
  description: The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.
  arm group label: group two's control（Spouse or sibling of group two)
  description: Only the risk factors will be investigated
  intervention type: Other
  intervention name: Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
  description: group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, RNF180/Septin9 gene methylation test, and investigation of risk factors, including past disease history, alcohol drinking history, smoking history, tea drinking history, family history of cancer, marital and reproductive status, and dietary habits.
  arm group label: group one
  intervention type: Other
  intervention name: Risk factor investigation;
  description: Only the risk factors will be investigated, including previous disease history, drinking history, smoking history, drinking history, family history of malignant tumor, marriage and childbearing status, eating habits, etc.
  arm group label: Group one's control（Spouse or sibling of group one )
  arm group label: group two's control（Spouse or sibling of group two)
  intervention type: Other
  intervention name: Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
  description: group two: The screening population will undergo investigation of risk factors, a fecal occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a stool occult blood test or H. pylori antigen is positive after testing, RNF180 and SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is positive, a colonoscopy will be scheduled.
  arm group label: group two
  Blood；tissue
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kaichun Wu
  role: Study Chair
  affiliation: Xijing Hospital
  last name: rong zheng
  phone: 19829758242
  email: zhengrong4956@163.com
  responsible party type: Sponsor
  mesh term: Digestive System Neoplasms
  mesh term: Gastrointestinal Neoplasms
  mesh term: Digestive System Diseases
  mesh term: Gastrointestinal Diseases
  sharing ipd: Undecided
  ipd description: According to the research process, choose a specific method to disclose the original data.