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/NCT06032338</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A01914-39</org_study_id>
      <nct_id>NCT06032338</nct_id>
    </id_info>
    <brief_title>Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering</brief_title>
    <acronym>EXPEDIT</acronym>
    <official_title>EXPérimentation d'Envoi Postal DIrect à Domicile du kiT de dépistage du Cancer Colorectal Sans Commande préalable [Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering]</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Caen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The effect of mailing FIT with the invitation on participation and colonoscopy rates will be&#xD;
        evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region,&#xD;
        involving 64,000 people from the population eligible for colorectal cancer population-based&#xD;
        organised screening program (CRC-PBOSP).&#xD;
  &#xD;
        In the &quot;C&quot; control group, invitations, test delivery and reminders will be carried out in&#xD;
        accordance with the CRC-PBOSP rules at the time of the study.&#xD;
  &#xD;
        Intervention group &quot;B&quot; will evaluate two experimental modes of invitation with direct home&#xD;
        mailing of the test:&#xD;
  &#xD;
          -  Method &quot;B1&quot;: invitation with test sent to home without prior information letter&#xD;
  &#xD;
          -  Method &quot;B2&quot;: information letter followed by invitation with test sent home, designed to&#xD;
             optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for&#xD;
             the first time.&#xD;
  &#xD;
        Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a&#xD;
        few general practitioners, gastroenterologists and invitees), 2/ on social and geographical&#xD;
        inequalities of participation on a subsample of individuals included in EXPEDIT study using&#xD;
        ecological indices (EDI, SCALE).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 14, 2023</start_date>
    <completion_date type="Anticipated">November 14, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 14, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The number of study arms will differ according to age-group:&#xD;
  In 50 or 51 yrs age-group, individuals (n=5760 ) will be randomised in 3 groups: C, B1 and B2 (allocation ratio 2:1:1)&#xD;
  In the age-group older than 51 yrs, individuals (n=58240) will be randomised in 2 groups: C, and B1 (allocation 1:1) In the main analysis including both age-groups, B1 and B2 arms would be pooled.</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Participation to CRC screening program</measure>
      <time_frame>16 months after the invitation</time_frame>
      <description>Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Performance of colonoscopy in FIT positive patients</measure>
      <time_frame>6 months after the positive FIT</time_frame>
      <description>Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participation to CRC screening program at 24 months</measure>
      <time_frame>24 months after invitation</time_frame>
      <description>Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to screening participation</measure>
      <time_frame>24 months after invitation</time_frame>
      <description>Time to screening participation within 24 months of invitation among invitees</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Colonoscopy in FIT positive patients, 12 months after the positive test</measure>
      <time_frame>12 months after the positive test</time_frame>
      <description>Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to colonoscopy (in FIT positive patients)</measure>
      <time_frame>12 months after the positive test</time_frame>
      <description>Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Colonoscopy findings</measure>
      <time_frame>12 months after the positive test</time_frame>
      <description>Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participation to CRC screening program in first invitees (50-51 yrs-old)</measure>
      <time_frame>16 months after invitation</time_frame>
      <description>Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness analysis</measure>
      <time_frame>24 months</time_frame>
      <description>Costs of CSC-PBOSP from invitation to colonoscopy when necessary</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">64000</enrollment>
    <condition>Colorectal Cancer</condition>
    <arm_group>
      <arm_group_label>Control &quot;C&quot;</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Usual care : Screening test (Fecal immunochemical test - FIT) delivery and reminders will be carried out in accordance with the Colorectal cancer population-based organised screening program (CRC-PBOSP) specifications at the time of the study.&#xD;
  This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention &quot;B1&quot;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>FIT mailed at home within the CRC screening invitation without prior information letter.&#xD;
  This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention &quot;B2&quot;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>FIT mailed at home within the CRC screening invitation with prior information letter.&#xD;
  This arm is suitable for the first screening round in 50-51 years old population only.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CRC screening invitation not including the screening test.</intervention_name>
      <description>The invitation to CRC-PBOSP will only contain informations on how to get the screening test.</description>
      <arm_group_label>Control &quot;C&quot;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mailing of FIT with invitation</intervention_name>
      <description>The invitation to CRC-PBOSP will contain the CRC screening test.</description>
      <arm_group_label>Intervention &quot;B1&quot;</arm_group_label>
      <arm_group_label>Intervention &quot;B2&quot;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Information letter before invitation</intervention_name>
      <description>An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.</description>
      <arm_group_label>Intervention &quot;B2&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  50 to 74 years old&#xD;
  &#xD;
            -  Resident of Centre Val de Loire French area&#xD;
  &#xD;
            -  Eligible for CRC screening invitation within the biennal CRC-PBOSP during the&#xD;
               inclusion period&#xD;
  &#xD;
            -  Affiliated to the health insurance scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round&#xD;
               (family or personal history of CRC/adenoma, inflammatory bowel disease)&#xD;
  &#xD;
            -  Colonoscopy in the previous 5 years)&#xD;
  &#xD;
          Subjects refusing data transmission to research team will be excluded from statistical&#xD;
          analyses.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lydia GUITTET, MD,PhD</last_name>
      <phone>+33(0)231065781</phone>
      <email>guittet-l@chu-caen.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Crcdc-Cvl</name>
        <address>
          <city>Tours</city>
          <zip>37000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Julie BOYARD, ScD</last_name>
        <email>j.boyard@depistage-cancer.fr</email>
      </contact>
      <investigator>
        <last_name>Julie BOYARD, ScD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Screening</keyword>
    <keyword>Participation</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>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/NCT06032338
  org study id: 2022-A01914-39
  nct id: NCT06032338
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The effect of mailing FIT with the invitation on participation and colonoscopy rates will be
        evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region,
        involving 64,000 people from the population eligible for colorectal cancer population-based
        organised screening program (CRC-PBOSP).
  
        In the "C" control group, invitations, test delivery and reminders will be carried out in
        accordance with the CRC-PBOSP rules at the time of the study.
  
        Intervention group "B" will evaluate two experimental modes of invitation with direct home
        mailing of the test:
  
          -  Method "B1": invitation with test sent to home without prior information letter
  
          -  Method "B2": information letter followed by invitation with test sent home, designed to
             optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for
             the first time.
  
        Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a
        few general practitioners, gastroenterologists and invitees), 2/ on social and geographical
        inequalities of participation on a subsample of individuals included in EXPEDIT study using
        ecological indices (EDI, SCALE).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The number of study arms will differ according to age-group:
  In 50 or 51 yrs age-group, individuals (n=5760 ) will be randomised in 3 groups: C, B1 and B2 (allocation ratio 2:1:1)
  In the age-group older than 51 yrs, individuals (n=58240) will be randomised in 2 groups: C, and B1 (allocation 1:1) In the main analysis including both age-groups, B1 and B2 arms would be pooled.
  primary purpose: Screening
  masking: None (Open Label)
  measure: Participation to CRC screening program
  time frame: 16 months after the invitation
  description: Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.
  measure: Performance of colonoscopy in FIT positive patients
  time frame: 6 months after the positive FIT
  description: Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT
  measure: Participation to CRC screening program at 24 months
  time frame: 24 months after invitation
  description: Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.
  measure: Time to screening participation
  time frame: 24 months after invitation
  description: Time to screening participation within 24 months of invitation among invitees
  measure: Colonoscopy in FIT positive patients, 12 months after the positive test
  time frame: 12 months after the positive test
  description: Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT
  measure: Time to colonoscopy (in FIT positive patients)
  time frame: 12 months after the positive test
  description: Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT
  measure: Colonoscopy findings
  time frame: 12 months after the positive test
  description: Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT
  measure: Participation to CRC screening program in first invitees (50-51 yrs-old)
  time frame: 16 months after invitation
  description: Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)
  measure: Cost-effectiveness analysis
  time frame: 24 months
  description: Costs of CSC-PBOSP from invitation to colonoscopy when necessary
  arm group label: Control "C"
  arm group type: Other
  description: Usual care : Screening test (Fecal immunochemical test - FIT) delivery and reminders will be carried out in accordance with the Colorectal cancer population-based organised screening program (CRC-PBOSP) specifications at the time of the study.
  This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.
  arm group label: Intervention "B1"
  arm group type: Experimental
  description: FIT mailed at home within the CRC screening invitation without prior information letter.
  This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds.
  arm group label: Intervention "B2"
  arm group type: Experimental
  description: FIT mailed at home within the CRC screening invitation with prior information letter.
  This arm is suitable for the first screening round in 50-51 years old population only.
  intervention type: Other
  intervention name: CRC screening invitation not including the screening test.
  description: The invitation to CRC-PBOSP will only contain informations on how to get the screening test.
  arm group label: Control "C"
  intervention type: Other
  intervention name: Mailing of FIT with invitation
  description: The invitation to CRC-PBOSP will contain the CRC screening test.
  arm group label: Intervention "B1"
  arm group label: Intervention "B2"
  intervention type: Other
  intervention name: Information letter before invitation
  description: An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.
  arm group label: Intervention "B2"
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 74 Years
  healthy volunteers: No
  last name: Lydia GUITTET, MD,PhD
  phone: +33(0)231065781
  email: guittet-l@chu-caen.fr
  facility: 
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: No