<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/NCT03750617</url>
  </required_header>
  <id_info>
    <org_study_id>xjtu-20170815</org_study_id>
    <nct_id>NCT03750617</nct_id>
  </id_info>
  <brief_title>Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps</brief_title>
  <official_title>Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy Screening of Colorectal Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State Key Laboratory of Cancer Biology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>State Key Laboratory of Cancer Biology</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>
      Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for&#xD;
      colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps&#xD;
      is still low. Therefore, we design this study to access whether pre-endoscopic screening risk&#xD;
      assessment of genetic and environmental risk factors could improve diagnosis rate of&#xD;
      colorectal polyps.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic rate of patients with polyps</measure>
    <time_frame>2 year</time_frame>
    <description>Diagnostic rate of patients with polyps</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and characteristics of polyps detected</measure>
    <time_frame>2 year</time_frame>
    <description>Characterization of types of polyps</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Colorectal Polyp</condition>
  <arm_group>
    <arm_group_label>pre-endoscopic screening risk assessment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>routine screening</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>pre-endoscopic screening risk assessment</intervention_name>
    <description>pre-endoscopic screening risk assessment</description>
    <arm_group_label>pre-endoscopic screening risk assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-65.&#xD;
&#xD;
          2. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe back ground disease including malignancy.&#xD;
&#xD;
          2. State after gastric surgery.&#xD;
&#xD;
          3. COPD, CHF, CRF and any disease with respiratory disturbances.&#xD;
&#xD;
          4. Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any&#xD;
             other technical problem prevents gastric acid collection or base excess evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dake Chu, M.D.</last_name>
    <phone>86-29-85323922</phone>
    <email>chudake@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>State Key laboratory of Cancer Biology</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dake Chu, M.D.</last_name>
      <email>chudake@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>March 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State Key Laboratory of Cancer Biology</investigator_affiliation>
    <investigator_full_name>Dake Chu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Colorectal Polyp</keyword>
  <keyword>Screening</keyword>
  <keyword>Risk assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyps</mesh_term>
  </condition_browse>
  <!-- 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/NCT03750617
org study id: xjtu-20170815
nct id: NCT03750617
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for
      colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps
      is still low. Therefore, we design this study to access whether pre-endoscopic screening risk
      assessment of genetic and environmental risk factors could improve diagnosis rate of
      colorectal polyps.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Diagnostic rate of patients with polyps
time frame: 2 year
description: Diagnostic rate of patients with polyps
measure: Number and characteristics of polyps detected
time frame: 2 year
description: Characterization of types of polyps
arm group label: pre-endoscopic screening risk assessment
arm group type: Experimental
arm group label: routine screening
arm group type: No Intervention
intervention type: Diagnostic Test
intervention name: pre-endoscopic screening risk assessment
description: pre-endoscopic screening risk assessment
arm group label: pre-endoscopic screening risk assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dake Chu, M.D.
phone: 86-29-85323922
email: chudake@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: State Key Laboratory of Cancer Biology
investigator full name: Dake Chu
investigator title: Principal Investigator
mesh term: Polyps