xml: <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/NCT05976282</url>
    </required_header>
    <id_info>
      <org_study_id>20150905</org_study_id>
      <secondary_id>NCI-2023-00172</secondary_id>
      <nct_id>NCT05976282</nct_id>
    </id_info>
    <brief_title>Addressing Colorectal Cancer in South Florida Firefighters</brief_title>
    <official_title>Addressing Colorectal Cancer in South Florida Firefighters</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Florida</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Miami</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The standard way of screening for colorectal cancer is to have a series of fecal blood tests,&#xD;
        where a sample is taken from a participant's stool, or an endoscopic procedure performed by a&#xD;
        doctor, where a camera is used to look inside the bowel. This research study will use a test&#xD;
        performed by the participant. This test will look for changes in the stool that can identify&#xD;
        if participants are at higher risk for cancer.&#xD;
  &#xD;
        Another aim of this study is to better understand what firefighters and retired firefighters&#xD;
        think about colorectal cancer and other health issues. This information will help us develop&#xD;
        programs that may improve colorectal cancer outcomes in the firefighter community.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 15, 2016</start_date>
    <completion_date type="Actual">November 19, 2019</completion_date>
    <primary_completion_date type="Actual">December 12, 2018</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of Participants Completing FIT Screening Tool</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Feasibility will be measured as the percentage of eligible participants completing the FIT screening tool. Criterion for success: 65% of all eligible participants complete the FIT screening tool.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of FIT Specimens Adequate for Lab Processing</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Feasibility will be measured as the percentage of FIT specimens collected from participants that are adequate for processing. Criterion for success: 95% of all FIT specimens are adequate for lab processing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Feasibility will be measured as the percentage of participants with positive FIT results who comply with the necessary follow-up for colonoscopy. Criterion for success: 85% of all participants with positive FIT results comply with necessary follow up for colonoscopy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of Participants Who Feel FIT is an Acceptable Method of Screening</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Acceptability will be measured as the percentage of participants who feel the FIT is an acceptable method of screening. Criterion for success: 90% of participants who complete the FIT find it to be an acceptable method of screening.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">646</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>CRC</condition>
    <arm_group>
      <arm_group_label>FIT Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants aged 40-65 years will receive the self-administered FIT test by mail including instructions for obtaining and returning their stool specimens. Participants will be in this group for up to 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Septin9 Test Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants aged 50-65 years who declined the initial offer of FIT, will complete a 10-15 minute questionnaire about their personal health, quality of life, and health-related to colorectal cancer including screening history and smoking. Participants will be in this group for up to 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fecal Immunochemical Test</intervention_name>
      <description>The Fecal Immunochemical Test (FIT) is self-administered one-time for participants, per standard of care. This allows participants to obtain their own stool specimens from bowel movements without having a regular colorectal screening procedure in the doctor's office. Participants will use the FIT at the time of their next bowel movement and return their specimens to the laboratory by mail on the same or next day.</description>
      <arm_group_label>FIT Group</arm_group_label>
      <other_name>FIT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Septin9 Test</intervention_name>
      <description>Septin9 (SEPT9) is a blood-based test that will be offered to eligible participants one-time who refused the FIT. Participants will undergo a blood draw collected by a nurse or certified phlebotomist, 90 days after their refusal of the initial offer of FIT.</description>
      <arm_group_label>Septin9 Test Group</arm_group_label>
      <other_name>SEPT9</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For this study, participation is open to active and retired firefighters:&#xD;
  &#xD;
                 1. ≥ 40 and ≤ 65 years of age,&#xD;
  &#xD;
                 2. who work or worked in Florida Fire and Rescue departments and&#xD;
  &#xD;
                 3. report never having fecal occult blood test (FOBT) or sigmoidoscopy/colonoscopy&#xD;
                    in their life or only one FOBT in the past year, a sigmoidoscopy in the last 5&#xD;
                    years or a colonoscopy in the last 10 years. The research assistant will assess&#xD;
                    eligibility using a brief screener that will be completed online via RedCAP.&#xD;
  &#xD;
            -  For years 2 and 3 of the study, the investigators will enroll previously eligible&#xD;
               participants who did not complete colorectal cancer (CRC) screening during year 1. The&#xD;
               investigators will also enroll participants who completed fecal immunochemical test&#xD;
               (FIT) with our study during year 1 and 2. They will be contacted via RedCAP and a&#xD;
               follow up phone call at the 1 year mark of their previous screening. Based on national&#xD;
               guidelines, FIT screening is suggested on a yearly basis. The eligibility criteria&#xD;
               will be the same and participants will sign a revised informed consent form, stating&#xD;
               that they understand that they are being re-consented for the same study.&#xD;
  &#xD;
            -  Participants, ages 50-65 years old, meeting the above criteria who declined the&#xD;
               offered standard-of-care FIT will then be offered the blood-based septin9 test 90 days&#xD;
               from the initial offering. FDA guidelines require the participant to be at least 50&#xD;
               years old to participate in the septin9 blood collection. The blood based test will be&#xD;
               collected by a nurse or certified phlebotomist in the community setting.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals, who have a personal history of CRC, inflammatory bowel disease (ie, Crohn&#xD;
               disease involving the colon or ulcerative colitis) will be excluded from participation&#xD;
               as these conditions increase the likelihood of positive test results not associated&#xD;
               with the onset or recurrence of CRC disease. Additionally, individuals will be&#xD;
               excluded if they are not physically capable of performing the FIT themselves.&#xD;
  &#xD;
            -  Adults unable to consent&#xD;
  &#xD;
            -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Prisoners&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Erin Kobetz-Kerman, Phd, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Erin Kobetz-Kerman, PhD, MPH</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976282
  org study id: 20150905
  secondary id: NCI-2023-00172
  nct id: NCT05976282
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The standard way of screening for colorectal cancer is to have a series of fecal blood tests,
        where a sample is taken from a participant's stool, or an endoscopic procedure performed by a
        doctor, where a camera is used to look inside the bowel. This research study will use a test
        performed by the participant. This test will look for changes in the stool that can identify
        if participants are at higher risk for cancer.
  
        Another aim of this study is to better understand what firefighters and retired firefighters
        think about colorectal cancer and other health issues. This information will help us develop
        programs that may improve colorectal cancer outcomes in the firefighter community.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Feasibility of Participants Completing FIT Screening Tool
  time frame: Up to 6 months
  description: Feasibility will be measured as the percentage of eligible participants completing the FIT screening tool. Criterion for success: 65% of all eligible participants complete the FIT screening tool.
  measure: Feasibility of FIT Specimens Adequate for Lab Processing
  time frame: Up to 6 months
  description: Feasibility will be measured as the percentage of FIT specimens collected from participants that are adequate for processing. Criterion for success: 95% of all FIT specimens are adequate for lab processing.
  measure: Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy
  time frame: Up to 6 months
  description: Feasibility will be measured as the percentage of participants with positive FIT results who comply with the necessary follow-up for colonoscopy. Criterion for success: 85% of all participants with positive FIT results comply with necessary follow up for colonoscopy.
  measure: Acceptability of Participants Who Feel FIT is an Acceptable Method of Screening
  time frame: Up to 6 months
  description: Acceptability will be measured as the percentage of participants who feel the FIT is an acceptable method of screening. Criterion for success: 90% of participants who complete the FIT find it to be an acceptable method of screening.
  arm group label: FIT Group
  arm group type: Experimental
  description: Participants aged 40-65 years will receive the self-administered FIT test by mail including instructions for obtaining and returning their stool specimens. Participants will be in this group for up to 6 months.
  arm group label: Septin9 Test Group
  arm group type: Experimental
  description: Participants aged 50-65 years who declined the initial offer of FIT, will complete a 10-15 minute questionnaire about their personal health, quality of life, and health-related to colorectal cancer including screening history and smoking. Participants will be in this group for up to 6 months.
  intervention type: Other
  intervention name: Fecal Immunochemical Test
  description: The Fecal Immunochemical Test (FIT) is self-administered one-time for participants, per standard of care. This allows participants to obtain their own stool specimens from bowel movements without having a regular colorectal screening procedure in the doctor's office. Participants will use the FIT at the time of their next bowel movement and return their specimens to the laboratory by mail on the same or next day.
  arm group label: FIT Group
  other name: FIT
  intervention type: Other
  intervention name: Septin9 Test
  description: Septin9 (SEPT9) is a blood-based test that will be offered to eligible participants one-time who refused the FIT. Participants will undergo a blood draw collected by a nurse or certified phlebotomist, 90 days after their refusal of the initial offer of FIT.
  arm group label: Septin9 Test Group
  other name: SEPT9
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Erin Kobetz-Kerman, Phd, MPH
  role: Principal Investigator
  affiliation: University of Miami
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Erin Kobetz-Kerman, PhD, MPH
  investigator title: Professor
  mesh term: Colorectal Neoplasms
  sharing ipd: No