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/NCT05998915</url>
    </required_header>
    <id_info>
      <org_study_id>CALM2102</org_study_id>
      <nct_id>NCT05998915</nct_id>
    </id_info>
    <brief_title>A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer</brief_title>
    <acronym>2102</acronym>
    <official_title>A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhujiang Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhujiang 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>
        As for this research，we want to find whether the intestinal microecology (flora,&#xD;
        peptidoglycan fragments) have certain distribution characteristics in colorectal diseases;&#xD;
        whether it can predict the development of disease/as a prognostic indicator.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We even want to find whether it can predict the development of disease/as a prognostic&#xD;
        indicator.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</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>collect specimen before colonscope</measure>
      <time_frame>Baseline (before colonscope)</time_frame>
      <description>collect fecal，saliva，urine，blood</description>
    </primary_outcome>
    <number_of_groups>6</number_of_groups>
    <enrollment type="Anticipated">5</enrollment>
    <condition>Human Microecology；Colorectal Disease；Auxiliary Diagnosis</condition>
    <arm_group>
      <arm_group_label>Colorectal Cancer(CRC)</arm_group_label>
      <description>People who is diagnosed with CRC by colonoscopy and pathological biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Inflammatory Bowel Disease</arm_group_label>
      <description>People who is diagnosed with IBD by colonoscopy and pathological biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Colorectal adenoma(CRA)/adenomatous polyposis</arm_group_label>
      <description>People who is diagnosed with CRA by colonoscopy and pathological biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-adenomatous polyps</arm_group_label>
      <description>People who is diagnosed with non-adenomatous polyps by colonoscopy and pathological biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Irritable bowel syndrome</arm_group_label>
      <description>People who is diagnosed with IBS by colonoscopy and pathological biopsy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>normal</arm_group_label>
      <description>People who has no obvious abnormality in the whole colon</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>observe only</intervention_name>
      <description>observe only</description>
      <arm_group_label>Colorectal Cancer(CRC)</arm_group_label>
      <arm_group_label>Colorectal adenoma(CRA)/adenomatous polyposis</arm_group_label>
      <arm_group_label>Inflammatory Bowel Disease</arm_group_label>
      <arm_group_label>Irritable bowel syndrome</arm_group_label>
      <arm_group_label>Non-adenomatous polyps</arm_group_label>
      <arm_group_label>normal</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          2500&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  people who is going to get the colonoscopy examination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  people who was diagnosed as one cancer，expect for CRC; who has had the antibiotics or&#xD;
               the medicine that treats for colorectal disease, except for medical probiotics, in one&#xD;
               month; who has had the laxative and the colonscopy in one week; who had a operation in&#xD;
               three month.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>钟 典</last_name>
      <phone>18928794133</phone>
      <email>vmojito@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhujiang Hospital of Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongwei Zhou, Professor</last_name>
        <phone>18688489622</phone>
        <email>hzhou@smu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Disease</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/NCT05998915
  org study id: CALM2102
  nct id: NCT05998915
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  As for this research，we want to find whether the intestinal microecology (flora,
        peptidoglycan fragments) have certain distribution characteristics in colorectal diseases;
        whether it can predict the development of disease/as a prognostic indicator.
  We even want to find whether it can predict the development of disease/as a prognostic
        indicator.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: collect specimen before colonscope
  time frame: Baseline (before colonscope)
  description: collect fecal，saliva，urine，blood
  arm group label: Colorectal Cancer(CRC)
  description: People who is diagnosed with CRC by colonoscopy and pathological biopsy
  arm group label: Inflammatory Bowel Disease
  description: People who is diagnosed with IBD by colonoscopy and pathological biopsy
  arm group label: Colorectal adenoma(CRA)/adenomatous polyposis
  description: People who is diagnosed with CRA by colonoscopy and pathological biopsy
  arm group label: Non-adenomatous polyps
  description: People who is diagnosed with non-adenomatous polyps by colonoscopy and pathological biopsy
  arm group label: Irritable bowel syndrome
  description: People who is diagnosed with IBS by colonoscopy and pathological biopsy
  arm group label: normal
  description: People who has no obvious abnormality in the whole colon
  intervention type: Other
  intervention name: observe only
  description: observe only
  arm group label: Colorectal Cancer(CRC)
  arm group label: Colorectal adenoma(CRA)/adenomatous polyposis
  arm group label: Inflammatory Bowel Disease
  arm group label: Irritable bowel syndrome
  arm group label: Non-adenomatous polyps
  arm group label: normal
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: 钟 典
  phone: 18928794133
  email: vmojito@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Disease