<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/NCT02986308</url>
  </required_header>
  <id_info>
    <org_study_id>Wei Xu</org_study_id>
    <nct_id>NCT02986308</nct_id>
  </id_info>
  <brief_title>The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types</brief_title>
  <official_title>The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heilongjiang University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Harbin Medical University</source>
  <brief_summary>
    <textblock>
      The aim of this study is to confirm the TCM syndrome types and TCM constitution&#xD;
      classifications of the patients with intestinal polyps via on-site epidemiological survey, to&#xD;
      analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to&#xD;
      study the metabolomics differences of the two populations and the metabolomics variations of&#xD;
      the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this&#xD;
      study is to investigate the serum metabolomics variations of patients with intestinal polyps&#xD;
      of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types&#xD;
      and TCM constitution classifications, to determine the correlation among pathology, TCM&#xD;
      constitution, TCM syndrome types and the metabonomics variations of patients with intestinal&#xD;
      polyps.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2016</start_date>
  <completion_date type="Actual">February 19, 2019</completion_date>
  <primary_completion_date type="Actual">January 21, 2019</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>10 Days</target_duration>
  <primary_outcome>
    <measure>Aiming to obtain biomarker groups of different pathological types of intestinal polyps, The potential biomarkers will be entered KEGG database to obtain metabolic pathways.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>All data matrices are introduced to Ezinfo software for PCA and OPLS-DA. Using improved &quot;MetPA enriched pathways&quot; method to discover the metabolic pathways of the disease.</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1659</enrollment>
  <condition>Intestinal Polyps</condition>
  <arm_group>
    <arm_group_label>Intestinal Polyps</arm_group_label>
    <description>The patients who were diagnosed with Intestinal Polyps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal colonoscopy</arm_group_label>
    <description>People who were diagnosed by colonoscopy without intestinal polyps.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <arm_group_label>Intestinal Polyps</arm_group_label>
    <arm_group_label>Normal colonoscopy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Intestinal polyps patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 20 to 80,all genders;&#xD;
&#xD;
          2. Intestinal polyps were found by colonoscopy;&#xD;
&#xD;
          3. The patients are scheduled for polypectomy;&#xD;
&#xD;
          4. Preoperative examinations were completed;&#xD;
&#xD;
          5. Performance status 0-1;&#xD;
&#xD;
          6. Diet has well controlled prior to the operation;&#xD;
&#xD;
          7. Patients or their statutory agent have signed the informed consent forms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient has not diagnosed by colonoscopy;&#xD;
&#xD;
          2. The patient has surgical contraindication;&#xD;
&#xD;
          3. Patients in pregnant or lactational period ;&#xD;
&#xD;
          4. Psychopath;&#xD;
&#xD;
          5. The patient is in drug trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Xu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Harbin Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Wei Xu</investigator_full_name>
    <investigator_title>MD,Professor</investigator_title>
  </responsible_party>
  <keyword>Metabolomics</keyword>
  <keyword>Intestinal Polyps</keyword>
  <keyword>TCM Syndromes</keyword>
  <keyword>TCM Constitution Types</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Intestinal Polyps</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/NCT02986308
org study id: Wei Xu
nct id: NCT02986308
lead sponsor: 
collaborator: 
The aim of this study is to confirm the TCM syndrome types and TCM constitution
      classifications of the patients with intestinal polyps via on-site epidemiological survey, to
      analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to
      study the metabolomics differences of the two populations and the metabolomics variations of
      the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this
      study is to investigate the serum metabolomics variations of patients with intestinal polyps
      of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types
      and TCM constitution classifications, to determine the correlation among pathology, TCM
      constitution, TCM syndrome types and the metabonomics variations of patients with intestinal
      polyps.
observational model: Case-Control
time perspective: Prospective
measure: Aiming to obtain biomarker groups of different pathological types of intestinal polyps, The potential biomarkers will be entered KEGG database to obtain metabolic pathways.
time frame: 2 years
measure: All data matrices are introduced to Ezinfo software for PCA and OPLS-DA. Using improved "MetPA enriched pathways" method to discover the metabolic pathways of the disease.
time frame: 3 days
arm group label: Intestinal Polyps
description: The patients who were diagnosed with Intestinal Polyps.
arm group label: Normal colonoscopy
description: People who were diagnosed by colonoscopy without intestinal polyps.
intervention type: Other
intervention name: No intervention
arm group label: Intestinal Polyps
arm group label: Normal colonoscopy
serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wei Xu, Doctor
role: Principal Investigator
affiliation: First Affiliated Hospital of Harbin Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Harbin Medical University
investigator full name: Wei Xu
investigator title: MD,Professor
mesh term: Polyps
mesh term: Intestinal Polyps
sharing ipd: No