<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/NCT03013855</url>
  </required_header>
  <id_info>
    <org_study_id>H-34258</org_study_id>
    <nct_id>NCT03013855</nct_id>
  </id_info>
  <brief_title>Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam</brief_title>
  <acronym>FIT-DRE</acronym>
  <official_title>Efficacy of Fecal Immunochemical Test Using Digital Rectal Exam</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for&#xD;
      the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in&#xD;
      pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for&#xD;
      spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition,&#xD;
      some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE.&#xD;
      This study aims to assess the correlation between FIT using the stool sample from DRE&#xD;
      (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators&#xD;
      may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help&#xD;
      avoid logistical barriers, as well as improve compliance and adherence to colon cancer&#xD;
      screening in the outpatient setting, eventually leading to improved quality of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fecal immunochemical testing (FIT) is an FDA-approved stool-based screening test for&#xD;
      colorectal cancer. It offers a less invasive colorectal cancer screening option for patients&#xD;
      who are not agreeable to colonoscopy and measures the level of Ab-globin complexes in the&#xD;
      stool without direct interference with diet or medications. FIT has been shown to be&#xD;
      selective for colorectal bleeding, as globin from the upper GI tract is digested by&#xD;
      proteolytic enzymes. A meta-analysis of studies analyzing FIT showed a pooled sensitivity of&#xD;
      0.79 (95% CI 0.69-0.86) and specificity was 0.94 (CI 0.92-0.95). In a large study comparing&#xD;
      FIT with another stool-based screening test, gFOBT, sensitivity of FIT was found to be&#xD;
      0.53-0.73 for CRC and 0.20-0.25 for advanced neoplasia compared to gFOBT, which showed 33.3%&#xD;
      for CRC and 8.6% for advanced neoplasia. In addition, FIT requires fewer stool samples and&#xD;
      the lack of dietary or medication modifications. As a result, compliance is likely to be&#xD;
      higher, which is crucial for cancer detection.&#xD;
&#xD;
      A challenge inherent to stool-based screening tests is compliance with sample submission by&#xD;
      the patients. FIT is meant to improve logistical barriers to screening because only one&#xD;
      sample is needed, however, compliance rates with standard of care FIT (FIT-SOC) is&#xD;
      approximately 50%. FIT using stool from a digital rectal exam (DRE) performed during a clinic&#xD;
      visit may be an effective screening tool for patients preferring stool-based screening. FIT&#xD;
      has been FDA-approved for the testing of spontaneously passed stool, as well as stool&#xD;
      collected by DRE. Manufacturers of FIT have claimed that DRE provides a sufficient amount of&#xD;
      stool for sampling, however, there are no validated studies to our knowledge which&#xD;
      demonstrate adequate efficacy. As a result, FIT using DRE is not commonly done in clinical&#xD;
      practice. This study aims to assess the correlation of FIT using DRE (FIT-DRE) with standard&#xD;
      of care FIT (FIT-SOC) as a method of obtaining stool samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit participants&#xD;
  </why_stopped>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concordance between standard FIT results and DRE FIT results.</measure>
    <time_frame>1 year</time_frame>
    <description>For example, the percentage of positive standard FIT results that also have positive DRE FIT results, and the percentage of negative standard FIT results that also have negative DRE FIT results.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Fecal Immunochemical Test</condition>
  <arm_group>
    <arm_group_label>FIT-SOC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fecal immunochemical test performed on spontaneously passed stool as noted in the standard instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FIT-DRE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fecal immunochemical test completed with stool collected during digital rectal exam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FIT-SOC</intervention_name>
    <description>Study subjects will be given a standard kit for fecal immunochemical test by their primary healthcare provider. As per standard practice, the patient will take the kit home and use the included FIT applicator to collect a stool sample from spontaneously passed stool during a regular bowel movement. The patient will then mail the stool sample to the lab in a pre-paid envelope, which is provided in the kit.</description>
    <arm_group_label>FIT-SOC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FIT-DRE</intervention_name>
    <description>Study subjects will have a digital rectal exam completed by their primary care providers during the physical exam portion of a routine clinic visit. The stool collected on the examiner's finger will be applied to the FIT applicator in the standard kit, which will then be sent to the lab for processing.</description>
    <arm_group_label>FIT-DRE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between the ages of 50-75 who are due for colon cancer screening and scheduled&#xD;
             for colonoscopy&#xD;
&#xD;
          -  Preoperative patients with established diagnosis of colon cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of Inflammatory Bowel Disease (IBD).&#xD;
&#xD;
          -  Patients who are pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Jacobson, MD</last_name>
    <role>Study Director</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.</citation>
    <PMID>24658694</PMID>
  </reference>
  <reference>
    <citation>Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer. 2013 Sep;49(14):3049-54. doi: 10.1016/j.ejca.2013.04.023. Epub 2013 May 22.</citation>
    <PMID>23706981</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Digital rectal exam</keyword>
  <keyword>Colon cancer screening</keyword>
  <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/NCT03013855
org study id: H-34258
nct id: NCT03013855
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study will investigate the use of digital rectal exam (DRE) to obtain stool samples for
      the fecal immunochemical test (FIT) in patients due for screening colonoscopy and in
      pre-operative patients with known colorectal cancer. FIT is currently FDA-approved for
      spontaneous stool and DRE, however, samples are not commonly obtained by DRE. In addition,
      some clinicians remain skeptical about the accuracy of FIT using stool obtained from DRE.
      This study aims to assess the correlation between FIT using the stool sample from DRE
      (FIT-DRE) and standard of care FIT (FIT-SOC). If good correlation is shown, the investigators
      may be able to demonstrate efficacy of FIT using a DRE in the clinic setting. This may help
      avoid logistical barriers, as well as improve compliance and adherence to colon cancer
      screening in the outpatient setting, eventually leading to improved quality of care.
Fecal immunochemical testing (FIT) is an FDA-approved stool-based screening test for
      colorectal cancer. It offers a less invasive colorectal cancer screening option for patients
      who are not agreeable to colonoscopy and measures the level of Ab-globin complexes in the
      stool without direct interference with diet or medications. FIT has been shown to be
      selective for colorectal bleeding, as globin from the upper GI tract is digested by
      proteolytic enzymes. A meta-analysis of studies analyzing FIT showed a pooled sensitivity of
      0.79 (95% CI 0.69-0.86) and specificity was 0.94 (CI 0.92-0.95). In a large study comparing
      FIT with another stool-based screening test, gFOBT, sensitivity of FIT was found to be
      0.53-0.73 for CRC and 0.20-0.25 for advanced neoplasia compared to gFOBT, which showed 33.3%
      for CRC and 8.6% for advanced neoplasia. In addition, FIT requires fewer stool samples and
      the lack of dietary or medication modifications. As a result, compliance is likely to be
      higher, which is crucial for cancer detection.

      A challenge inherent to stool-based screening tests is compliance with sample submission by
      the patients. FIT is meant to improve logistical barriers to screening because only one
      sample is needed, however, compliance rates with standard of care FIT (FIT-SOC) is
      approximately 50%. FIT using stool from a digital rectal exam (DRE) performed during a clinic
      visit may be an effective screening tool for patients preferring stool-based screening. FIT
      has been FDA-approved for the testing of spontaneously passed stool, as well as stool
      collected by DRE. Manufacturers of FIT have claimed that DRE provides a sufficient amount of
      stool for sampling, however, there are no validated studies to our knowledge which
      demonstrate adequate efficacy. As a result, FIT using DRE is not commonly done in clinical
      practice. This study aims to assess the correlation of FIT using DRE (FIT-DRE) with standard
      of care FIT (FIT-SOC) as a method of obtaining stool samples.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Concordance between standard FIT results and DRE FIT results.
time frame: 1 year
description: For example, the percentage of positive standard FIT results that also have positive DRE FIT results, and the percentage of negative standard FIT results that also have negative DRE FIT results.
arm group label: FIT-SOC
arm group type: Active Comparator
description: Fecal immunochemical test performed on spontaneously passed stool as noted in the standard instructions.
arm group label: FIT-DRE
arm group type: Experimental
description: Fecal immunochemical test completed with stool collected during digital rectal exam.
intervention type: Device
intervention name: FIT-SOC
description: Study subjects will be given a standard kit for fecal immunochemical test by their primary healthcare provider. As per standard practice, the patient will take the kit home and use the included FIT applicator to collect a stool sample from spontaneously passed stool during a regular bowel movement. The patient will then mail the stool sample to the lab in a pre-paid envelope, which is provided in the kit.
arm group label: FIT-SOC
intervention type: Device
intervention name: FIT-DRE
description: Study subjects will have a digital rectal exam completed by their primary care providers during the physical exam portion of a routine clinic visit. The stool collected on the examiner's finger will be applied to the FIT applicator in the standard kit, which will then be sent to the lab for processing.
arm group label: FIT-DRE
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brian Jacobson, MD
role: Study Director
affiliation: Boston Medical Center
facility: 
country: United States
citation: Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.
PMID: 24658694
citation: Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer. 2013 Sep;49(14):3049-54. doi: 10.1016/j.ejca.2013.04.023. Epub 2013 May 22.
PMID: 23706981
responsible party type: Sponsor
sharing ipd: Undecided