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/NCT06031779</url>
    </required_header>
    <id_info>
      <org_study_id>KY20232258-C-1</org_study_id>
      <nct_id>NCT06031779</nct_id>
    </id_info>
    <brief_title>Application of Serum Bile Acid Profile in the Diagnosis of Gastric Cancer</brief_title>
    <official_title>Application of Serum Bile Acid Profile in the Diagnosis of Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital of Digestive Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing Hospital of Digestive Diseases</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, the composition and level of serum bile acids in patients with gastric cancer&#xD;
        and non-gastric cancer were analyzed by detecting the serum bile acid profile, so as to&#xD;
        develop new serological diagnostic methods for early diagnosis and treatment of gastric&#xD;
        cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>serum bile acid profile before treatment</measure>
      <time_frame>1 month</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>concentration of serum tumor markers before treatment</measure>
      <time_frame>1 month</time_frame>
      <description>CEA, CA19-9 and CA12-5</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>gastric cancer</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>non-gastric cancer</arm_group_label>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        serum&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients attending Xijing Hospital and Patients included in the biospecimen bank&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18-70, both gender;&#xD;
  &#xD;
            2. The gastric cancer group was early gastric cancer or advanced gastric cancer diagnosed&#xD;
               by endoscopic examination and pathological biopsy. The non-gastric cancer group&#xD;
               included patients without gastric lesions, superficial gastritis, chronic atrophic&#xD;
               gastritis, intestinal metaplasia or dysplasia diagnosed by gastroscopy or pathological&#xD;
               biopsy;&#xD;
  &#xD;
            3. Informed consent was obtained.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The patients have diseases that affect bile acid metabolism, such as liver cirrhosis,&#xD;
               gallstones or inflammatory bowel disease, Behcet's disease, etc;&#xD;
  &#xD;
            2. Due to other diseases, the patient took drugs affecting bile acid metabolism, such as&#xD;
               cholestyramine, anti-inflammatory Lidan tablets, Danshu capsules, ursodeoxycholic&#xD;
               acid, obticholic acid, Schisandrin B, tanshinone ⅡA, Yinzhihuang, etc;&#xD;
  &#xD;
            3. Pregnant women;&#xD;
  &#xD;
            4. Primary tumors of other systems were diagnosed;&#xD;
  &#xD;
            5. Those with poor physiopathological conditions, such as chronic kidney disease&#xD;
               requiring long-term dialysis;&#xD;
  &#xD;
            6. Patients with mental illness;&#xD;
  &#xD;
            7. Patients who have received radiotherapy or surgery previously;&#xD;
  &#xD;
            8. Those with poor adherence or difficult to follow up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Yongquan Shi, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Xijing Hpsipital of Digestive Disease</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nuo Yao</last_name>
      <phone>+86 15319121701</phone>
      <email>785356949@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yongquan Shi, PhD</last_name>
      <phone>86-029-84771515</phone>
      <email>shiyquan@fmmu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Xijing Hosipital of Digestive Disease</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yongquan Shi, PhD</last_name>
        <phone>86-029-84771515</phone>
        <email>shiyquan@fmmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Xijing Hospital of Digestive Diseases</investigator_affiliation>
      <investigator_full_name>Yongquan Shi</investigator_full_name>
      <investigator_title>Principal Investigator,Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>serum bile acid</keyword>
    <keyword>biomarker</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06031779
  org study id: KY20232258-C-1
  nct id: NCT06031779
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the composition and level of serum bile acids in patients with gastric cancer
        and non-gastric cancer were analyzed by detecting the serum bile acid profile, so as to
        develop new serological diagnostic methods for early diagnosis and treatment of gastric
        cancer.
  observational model: Case-Control
  time perspective: Other
  measure: serum bile acid profile before treatment
  time frame: 1 month
  measure: concentration of serum tumor markers before treatment
  time frame: 1 month
  description: CEA, CA19-9 and CA12-5
  arm group label: gastric cancer
  arm group label: non-gastric cancer
  serum
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  last name: Yongquan Shi, PhD
  role: Study Director
  affiliation: Xijing Hpsipital of Digestive Disease
  last name: Nuo Yao
  phone: +86 15319121701
  email: 785356949@qq.com
  last name: Yongquan Shi, PhD
  phone: 86-029-84771515
  email: shiyquan@fmmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xijing Hospital of Digestive Diseases
  investigator full name: Yongquan Shi
  investigator title: Principal Investigator,Clinical Professor
  mesh term: Stomach Neoplasms