<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/NCT04454099</url>
  </required_header>
  <id_info>
    <org_study_id>2020SDU-QILU-524</org_study_id>
    <nct_id>NCT04454099</nct_id>
  </id_info>
  <brief_title>A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening</brief_title>
  <official_title>A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population</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>
      Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related&#xD;
      death can be prevented through fecal occult blood test screening. Because of economic and&#xD;
      high sensitivity, fecal immunochemical test is recommended for screening population of CRC.&#xD;
      The purpose of this study is to compare the accuracy of 4 different fecal occult blood&#xD;
      testing in medium and high risk screening population in Chinese.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number&#xD;
      of cancer-associated mortality. CRC screening has been shown to be effective in reducing the&#xD;
      incidence of, and mortality from, CRC. There are several recommended screening options for&#xD;
      screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT)&#xD;
      .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced&#xD;
      colorectal neoplasia but also has several disadvantages, including higher cost and poorer&#xD;
      compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based&#xD;
      fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes&#xD;
      quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of&#xD;
      hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use&#xD;
      FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in&#xD;
      screening population of CRC in Chinese. To add to the evidence on FIT performance&#xD;
      characteristics for detection of CRC, the investigators design this research to compare qFIT&#xD;
      with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them&#xD;
      is chemical and immunologic combined detection）in medium and high risk screening population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">March 18, 2021</completion_date>
  <primary_completion_date type="Actual">March 18, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of 4 kind of FOBTs to diagnose CRC.</measure>
    <time_frame>6 months</time_frame>
    <description>The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.</measure>
    <time_frame>6 months</time_frame>
    <description>The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.</measure>
    <time_frame>6 months</time_frame>
    <description>The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.</measure>
    <time_frame>6 months</time_frame>
    <description>Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Explore the cost-benefit ratio of one or two-sample of qFIT.</measure>
    <time_frame>6 month</time_frame>
    <description>Explore the cost-benefit ratio of one or two-sample of qFIT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore the reason of false positive of qFIT</measure>
    <time_frame>6 month</time_frame>
    <description>Calculate false positive rate of the 4 kind of FOBTs. and count the case number of inflammatory bowel disease, colonic diverticulitis, hemorrhoids, upper gastrointestinal disease or medical factors that cause false positive of qFIT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT</measure>
    <time_frame>6 month</time_frame>
    <description>Count sensitivity and specificity with or without patients who take aspirin or other anticoagulants.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Fecal Occult Blood Test</arm_group_label>
    <description>People in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>4 kind of FOBT and colonoscopy with pathological examination</intervention_name>
    <description>Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.</description>
    <arm_group_label>Fecal Occult Blood Test</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool sample&#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;
          -  Adults 50-75 years old;&#xD;
&#xD;
          -  Asia-Pacific Colorectal Screening score(APCS): medium or high risk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  APCS score: low risk;&#xD;
&#xD;
          -  People with history of intestinal surgery;&#xD;
&#xD;
          -  People with history of CRC;&#xD;
&#xD;
          -  People with history of inflammatory bowel disease, ischemic enteritis, vascular&#xD;
             malformation of intestine or other disease resulting in intestinal tract bleeding;&#xD;
&#xD;
          -  People with symptoms including visible rectal bleeding, hematuria, severe and acute&#xD;
             diarrhea and Bristol feces score 7th type;&#xD;
&#xD;
          -  Pregnancy, lactation or menstrual phase;&#xD;
&#xD;
          -  Severe congestive heart failure or other sever disease cause cannot tolerate&#xD;
             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>
  <reference>
    <citation>Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.</citation>
    <PMID>27769517</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 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 cancer</keyword>
  <keyword>fecal occult blood testing</keyword>
  <keyword>quantitative fecal immunochemical test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04454099
org study id: 2020SDU-QILU-524
nct id: NCT04454099
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related
      death can be prevented through fecal occult blood test screening. Because of economic and
      high sensitivity, fecal immunochemical test is recommended for screening population of CRC.
      The purpose of this study is to compare the accuracy of 4 different fecal occult blood
      testing in medium and high risk screening population in Chinese.
Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number
      of cancer-associated mortality. CRC screening has been shown to be effective in reducing the
      incidence of, and mortality from, CRC. There are several recommended screening options for
      screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT)
      .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced
      colorectal neoplasia but also has several disadvantages, including higher cost and poorer
      compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based
      fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes
      quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of
      hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use
      FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in
      screening population of CRC in Chinese. To add to the evidence on FIT performance
      characteristics for detection of CRC, the investigators design this research to compare qFIT
      with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them
      is chemical and immunologic combined detection）in medium and high risk screening population.
observational model: Other
time perspective: Prospective
measure: The accuracy of 4 kind of FOBTs to diagnose CRC.
time frame: 6 months
description: The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.
measure: The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
time frame: 6 months
description: The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
measure: The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.
time frame: 6 months
description: The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.
measure: Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.
time frame: 6 months
description: Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.
measure: Explore the cost-benefit ratio of one or two-sample of qFIT.
time frame: 6 month
description: Explore the cost-benefit ratio of one or two-sample of qFIT.
measure: Explore the reason of false positive of qFIT
time frame: 6 month
description: Calculate false positive rate of the 4 kind of FOBTs. and count the case number of inflammatory bowel disease, colonic diverticulitis, hemorrhoids, upper gastrointestinal disease or medical factors that cause false positive of qFIT.
measure: Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT
time frame: 6 month
description: Count sensitivity and specificity with or without patients who take aspirin or other anticoagulants.
arm group label: Fecal Occult Blood Test
description: People in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy.
intervention type: Diagnostic Test
intervention name: 4 kind of FOBT and colonoscopy with pathological examination
description: Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.
arm group label: Fecal Occult Blood Test
Stool sample
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
citation: Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.
PMID: 27769517
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Clinical Professor
mesh term: Colorectal Neoplasms
sharing ipd: Undecided