<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/NCT02251782</url>
  </required_header>
  <id_info>
    <org_study_id>SPR 0026</org_study_id>
    <nct_id>NCT02251782</nct_id>
  </id_info>
  <brief_title>Adherence to Minimally Invasive Testing</brief_title>
  <acronym>ADMIT</acronym>
  <official_title>Adherence to Minimally Invasive CRC Screening In Non-Adherent Patients Who Have Not Completed Colorectal Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epigenomics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Epigenomics, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden&#xD;
      and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually&#xD;
      screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test)&#xD;
      testing, both have patient-associated barriers that reduce their use. The combination of&#xD;
      bowel preparation and procedure time are barriers to colonoscopy, while stool handling as&#xD;
      part of the sampling protocol reduces FIT usage.&#xD;
&#xD;
      It has been hypothesized and supported by a variety of preference studies that the&#xD;
      availability of a blood-based assay for CRC screening would increase patient participation&#xD;
      and adherence to CRC screening by reducing barriers that prevent participation.&#xD;
&#xD;
      This study is designed to investigate the relative participation in CRC screening in average&#xD;
      risk, screening eligible patients with demonstrated non-adherence to guideline-recommended&#xD;
      screening modalities. Participation with the fecal immunochemical test (FIT) and the&#xD;
      blood-based Epi proColon® test will be examined. Screening eligible average-risk patients&#xD;
      identified as non-adherent by medical record will be eligible for the study. Potential&#xD;
      subjects will be recruited to participate in a study via mailing and/or at a clinic visit.&#xD;
      All study subjects will be enrolled at a clinic visit and will be randomized in two study&#xD;
      arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to&#xD;
      Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be&#xD;
      compared between those that accept and complete the blood test and those that accept and&#xD;
      complete the FIT test. A passive control, usual care arm will comprise subjects meeting&#xD;
      eligibility criteria, but not recruited for or participating in the study.&#xD;
&#xD;
      In conjunction with published data (Johnson et al, 2014), the relative utilization of the&#xD;
      blood test will be compared to the screening participation via FIT. Increased participation&#xD;
      with the Epi proColon blood test could increase screening rates in the non-adherent&#xD;
      population. Additionally, for those testing positive in the trial, the rate of adherence to&#xD;
      colonoscopy will be determined.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Comparison of Adherence to Screening for Each Group</measure>
    <time_frame>9 months</time_frame>
    <description>FIT Test Adherence: Adherence to the FIT Test is expressed as a percentage which is calculated as the number of subjects who complete stool testing within 42 days (6 weeks) divided by the total number of subjects enrolled in the FIT study arm.&#xD;
Epi proColon Test Adherence: Adherence to Epi proColon is expressed as a percentage which is calculated as the number of subjects with documented blood draw for the Epi proColon Test within 42 days (6 weeks) divided by the total number of subjects enrolled in the Epi proColon Test arm.&#xD;
Usual Care Test Adherence: Expressed as a percentage which is calculated as the number of subjects in the Usual Care Group with documented CRC screening (FIT or Colonoscopy) during the duration of the study, divided by the total number of subjects in the usual care group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to follow-up colonoscopy for tests with a positive result:</measure>
    <time_frame>9 months</time_frame>
    <description>Documentation of colonoscopy completed within 42 days (6 weeks) after notification of positive test result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of colonoscopy:</measure>
    <time_frame>9 months</time_frame>
    <description>Documentation of colonoscopy findings.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">490</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Epi proColon Group</arm_group_label>
    <description>Subjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FIT Group</arm_group_label>
    <description>Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <description>For the purpose of comparison to usual care, participating health systems will build an anonymized group of patients meeting study eligibility criteria, who do not participate in the study. This group will serve as a passive control and their CRC screening activity will be monitored via Medical Record.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Epi proColon Test</intervention_name>
    <description>Subjects assigned to the Epi proColon arm will receive information on the Epi proColon test outlined in a template script. They will then be offered a blood draw for Epi proColon testing. The blood draw can be fulfilled at the clinic or at a specified blood draw station, at the convenience of the patient. Epi proColon plasma samples will be sent to a central laboratory for testing. If no test result is recorded within 4 weeks, patients will be mailed a reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.</description>
    <arm_group_label>Epi proColon Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fecal Immunochemical Test (FIT)</intervention_name>
    <description>Subjects assigned to the FIT arm will receive information on the FIT test outlined in a template script. They will then be provided a FIT kit to take home and asked to send a stool sample to the testing lab following the kit instructions. If no test result is recorded within 4 weeks, subjects will receive a mailed reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.</description>
    <arm_group_label>FIT Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will encompass users of outpatient primary care clinics of one or more&#xD;
        health care systems who are considered to be at average-risk for developing colorectal&#xD;
        cancer (CRC), have not completed standard screening options, and are not up-to-date with a&#xD;
        screening program. Such health care systems may include large healthcare networks with&#xD;
        relatively stable patient bases such as Geisinger Health Systems (Danville, PA), Kaiser&#xD;
        Permanente (Portland, OR).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 years of age or greater, but less than 76 years old&#xD;
&#xD;
          -  Has not completed recommended screening for colonoscopy or FIT&#xD;
&#xD;
               -  No colonoscopy in previous 10 years&#xD;
&#xD;
               -  No fecal occult blood test (FOBT) or FIT in previous year and/or &gt; 13 months late&#xD;
                  FIT&#xD;
&#xD;
          -  No flexible sigmoidoscopy in previous 5 years&#xD;
&#xD;
          -  Verifiable offer of screening recommendation according to health system standard in at&#xD;
             least two independent interactions and a verifiable lack of adherence for two most&#xD;
             recent&#xD;
&#xD;
          -  Verifiable lack of adherence for &gt;3 months following last screening recommendation&#xD;
&#xD;
          -  Primary Care Provider (PCP) has agreed to refer patients for consideration of&#xD;
             enrollment in the study&#xD;
&#xD;
          -  Subject able to understand and sign written informed consent (IC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family history of CRC in a first-degree relative&#xD;
&#xD;
          -  Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease&#xD;
&#xD;
          -  Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed&#xD;
             (hematochezia, new onset diarrhea or constipation, abdominal pain)&#xD;
&#xD;
          -  Comorbid illness precluding endoscopic evaluation (coronary artery disease with&#xD;
             myocardial infarction within 6 months, unstable angina or congestive heart failure,&#xD;
             chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit&#xD;
             life expectancy to less than 10 years)&#xD;
&#xD;
          -  Chronic gastritis, pregnancy, cancer(s) other than colorectal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theo deVos, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Director Development &amp; Commercial Operations</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Center for Health Research</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Clinic</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://epigenomics.com</url>
    <description>Epigenomics Homepage</description>
  </link>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>June 29, 2015</last_update_submitted>
  <last_update_submitted_qc>June 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT02251782
org study id: SPR 0026
nct id: NCT02251782
lead sponsor: 
has dmc: No
Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden
      and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually
      screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test)
      testing, both have patient-associated barriers that reduce their use. The combination of
      bowel preparation and procedure time are barriers to colonoscopy, while stool handling as
      part of the sampling protocol reduces FIT usage.

      It has been hypothesized and supported by a variety of preference studies that the
      availability of a blood-based assay for CRC screening would increase patient participation
      and adherence to CRC screening by reducing barriers that prevent participation.

      This study is designed to investigate the relative participation in CRC screening in average
      risk, screening eligible patients with demonstrated non-adherence to guideline-recommended
      screening modalities. Participation with the fecal immunochemical test (FIT) and the
      blood-based Epi proColon® test will be examined. Screening eligible average-risk patients
      identified as non-adherent by medical record will be eligible for the study. Potential
      subjects will be recruited to participate in a study via mailing and/or at a clinic visit.
      All study subjects will be enrolled at a clinic visit and will be randomized in two study
      arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to
      Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be
      compared between those that accept and complete the blood test and those that accept and
      complete the FIT test. A passive control, usual care arm will comprise subjects meeting
      eligibility criteria, but not recruited for or participating in the study.

      In conjunction with published data (Johnson et al, 2014), the relative utilization of the
      blood test will be compared to the screening participation via FIT. Increased participation
      with the Epi proColon blood test could increase screening rates in the non-adherent
      population. Additionally, for those testing positive in the trial, the rate of adherence to
      colonoscopy will be determined.
observational model: Case-Control
time perspective: Prospective
measure: Comparison of Adherence to Screening for Each Group
time frame: 9 months
description: FIT Test Adherence: Adherence to the FIT Test is expressed as a percentage which is calculated as the number of subjects who complete stool testing within 42 days (6 weeks) divided by the total number of subjects enrolled in the FIT study arm.
Epi proColon Test Adherence: Adherence to Epi proColon is expressed as a percentage which is calculated as the number of subjects with documented blood draw for the Epi proColon Test within 42 days (6 weeks) divided by the total number of subjects enrolled in the Epi proColon Test arm.
Usual Care Test Adherence: Expressed as a percentage which is calculated as the number of subjects in the Usual Care Group with documented CRC screening (FIT or Colonoscopy) during the duration of the study, divided by the total number of subjects in the usual care group
measure: Adherence to follow-up colonoscopy for tests with a positive result:
time frame: 9 months
description: Documentation of colonoscopy completed within 42 days (6 weeks) after notification of positive test result
measure: Diagnostic yield of colonoscopy:
time frame: 9 months
description: Documentation of colonoscopy findings.
arm group label: Epi proColon Group
description: Subjects assigned to the Epi proColon Group will be offered the Epi proColon test for colorectal cancer screening.
arm group label: FIT Group
description: Subjects in the FIT Group will be offered a fecal immunochemical test (FIT test) for colorectal cancer screening.
arm group label: Usual Care Group
description: For the purpose of comparison to usual care, participating health systems will build an anonymized group of patients meeting study eligibility criteria, who do not participate in the study. This group will serve as a passive control and their CRC screening activity will be monitored via Medical Record.
intervention type: Device
intervention name: Epi proColon Test
description: Subjects assigned to the Epi proColon arm will receive information on the Epi proColon test outlined in a template script. They will then be offered a blood draw for Epi proColon testing. The blood draw can be fulfilled at the clinic or at a specified blood draw station, at the convenience of the patient. Epi proColon plasma samples will be sent to a central laboratory for testing. If no test result is recorded within 4 weeks, patients will be mailed a reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
arm group label: Epi proColon Group
intervention type: Device
intervention name: Fecal Immunochemical Test (FIT)
description: Subjects assigned to the FIT arm will receive information on the FIT test outlined in a template script. They will then be provided a FIT kit to take home and asked to send a stool sample to the testing lab following the kit instructions. If no test result is recorded within 4 weeks, subjects will receive a mailed reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
arm group label: FIT Group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 76 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Theo deVos, Ph.D.
role: Study Director
affiliation: Director Development & Commercial Operations
facility: 
facility: 
country: United States
url: http://epigenomics.com
description: Epigenomics Homepage
responsible party type: Sponsor
mesh term: Colorectal Neoplasms