<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/NCT04473677</url>
  </required_header>
  <id_info>
    <org_study_id>2020SDU-QILU-708</org_study_id>
    <nct_id>NCT04473677</nct_id>
  </id_info>
  <brief_title>A New Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma</brief_title>
  <official_title>A New Quantitative Fecal Immunochemical Test Can Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</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>
      Early detecting and removing of colorectal advanced adenomas can reduce incidence of&#xD;
      colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of&#xD;
      existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology&#xD;
      qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared&#xD;
      with existing commercially available qFIT, is developed and this study will prove the high&#xD;
      diagnostic accuracy in detecting colorectal advanced adenoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and&#xD;
      cancer-related deaths worldwide. With progress of developing countries, it is predicted that&#xD;
      the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035.&#xD;
      The majority of colorectal cancer is thought to arise from precancerous lesions through the&#xD;
      adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce&#xD;
      incidence of colorectal cancer. Although colonoscopy is currently considered the most&#xD;
      effective method for detecting advanced adenomas, individuals may be reluctant to undergo&#xD;
      colonoscopy due to the uncomfortable feeling and the relatively high cost of colonoscopy.&#xD;
      Conversely, stool tests are relatively cheap and more readily accepted. Annual fecal&#xD;
      immunochemical test (FIT), one of the preferred methods of colorectal cancer screening, is&#xD;
      economic and easy to use. However, the existing commercially available qFIT is insufficiently&#xD;
      sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27%&#xD;
      to 47%. To improve diagnostic accuracy in detecting colorectal advanced adenoma, an improved&#xD;
      technology of qFIT, which have a higher sensitivity in extremely low concentration of&#xD;
      hemoglobin in stool compared with existing commercially available qFIT, is developed. The&#xD;
      investigators design this research to prove the diagnostic accuracy of the new qFIT in&#xD;
      detecting colorectal advanced adenoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">June 11, 2021</completion_date>
  <primary_completion_date type="Actual">June 11, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of the new qFIT to diagnose colorectal advanced adenoma.</measure>
    <time_frame>18 months</time_frame>
    <description>The sensitivity, specificity, positive predictive value and negative predictive value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The accuracy of the new qFIT to diagnose colorectal cancer.</measure>
    <time_frame>18 months</time_frame>
    <description>The sensitivity, specificity, positive predictive value and negative predictive value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT.</measure>
    <time_frame>18 months</time_frame>
    <description>Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT, age , sex, colorectal cancer family history, diet and so on.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1600</enrollment>
  <condition>Colorectal Adenoma</condition>
  <condition>Colorectal Neoplasm</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Fecal Occult Blood Test</arm_group_label>
    <description>People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The new qFIT and colonoscopy with pathological examination</intervention_name>
    <description>Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.</description>
    <arm_group_label>Fecal Occult Blood Test</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      stool samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Continuous participants intending to undergo colonoscopy and meet the inclusion and&#xD;
        exclusion criteria from Qilu Hospital were enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50-75 years old people;&#xD;
&#xD;
          -  People sign an &quot;informed consent form&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with history of surgery in any part of the large bowel;&#xD;
&#xD;
          -  People with history of colorectal cancer;&#xD;
&#xD;
          -  People with history of other diseases that may produce fecal blood, such as active&#xD;
             diverticulitis, inflammatory bowel disease, ischemic enteritis, vascular malformation&#xD;
             of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive&#xD;
             tract;&#xD;
&#xD;
          -  People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds,&#xD;
             severe and acute diarrhea and 7th type stool (Bristol feces score);&#xD;
&#xD;
          -  People are in pregnancy, lactation or menstrual phase;&#xD;
&#xD;
          -  People with severe congestive heart failure or other sever disease cause cannot&#xD;
             tolerate colonoscopy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqing Li, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qilu Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Colorectal Adenoma</keyword>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Occult Bleeding</keyword>
  <keyword>quantitative fecal immunochemical test</keyword>
  <keyword>Colorectal Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenoma</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/NCT04473677
org study id: 2020SDU-QILU-708
nct id: NCT04473677
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Early detecting and removing of colorectal advanced adenomas can reduce incidence of
      colorectal cancer. Because of the less bleeding of advanced adenomas, the sensitivity of
      existing quantitative fecal immunochemical test (qFIT) is unsatisfying. A new technology
      qFIT, which have a higher sensitivity in extremely low concentration of hemoglobin compared
      with existing commercially available qFIT, is developed and this study will prove the high
      diagnostic accuracy in detecting colorectal advanced adenoma.
Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and
      cancer-related deaths worldwide. With progress of developing countries, it is predicted that
      the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035.
      The majority of colorectal cancer is thought to arise from precancerous lesions through the
      adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce
      incidence of colorectal cancer. Although colonoscopy is currently considered the most
      effective method for detecting advanced adenomas, individuals may be reluctant to undergo
      colonoscopy due to the uncomfortable feeling and the relatively high cost of colonoscopy.
      Conversely, stool tests are relatively cheap and more readily accepted. Annual fecal
      immunochemical test (FIT), one of the preferred methods of colorectal cancer screening, is
      economic and easy to use. However, the existing commercially available qFIT is insufficiently
      sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27%
      to 47%. To improve diagnostic accuracy in detecting colorectal advanced adenoma, an improved
      technology of qFIT, which have a higher sensitivity in extremely low concentration of
      hemoglobin in stool compared with existing commercially available qFIT, is developed. The
      investigators design this research to prove the diagnostic accuracy of the new qFIT in
      detecting colorectal advanced adenoma.
observational model: Cohort
time perspective: Prospective
measure: The accuracy of the new qFIT to diagnose colorectal advanced adenoma.
time frame: 18 months
description: The sensitivity, specificity, positive predictive value and negative predictive value.
measure: The accuracy of the new qFIT to diagnose colorectal cancer.
time frame: 18 months
description: The sensitivity, specificity, positive predictive value and negative predictive value.
measure: Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT.
time frame: 18 months
description: Develop a predictive model of advanced colorectal neoplasms which includes the value of qFIT, age , sex, colorectal cancer family history, diet and so on.
arm group label: Fecal Occult Blood Test
description: People in this group will detect hemoglobin in stool before colonoscopy by the new qFIT.
intervention type: Diagnostic Test
intervention name: The new qFIT and colonoscopy with pathological examination
description: Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.
arm group label: Fecal Occult Blood Test
stool samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yanqing Li, PhD
role: Study Chair
affiliation: Qilu Hospital, Shandong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Clinical Professor
mesh term: Colorectal Neoplasms
mesh term: Adenoma