<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/NCT03790475</url>
  </required_header>
  <id_info>
    <org_study_id>43/PB/2018</org_study_id>
    <nct_id>NCT03790475</nct_id>
  </id_info>
  <brief_title>Participation in Competing Strategies for Colorectal Cancer Screening - a Randomized Health Services Study Within the National Screening Program in Poland</brief_title>
  <acronym>PICCOLINO</acronym>
  <official_title>Participation In Competing Strategies for COLorectal Cancer screenINg - a randOmized Health Services Study Within the National Screening Program in Poland(PICCOLINO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Sklodowska-Curie National Research Institute of Oncology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre of Postgraduate Medical Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maria Sklodowska-Curie National Research Institute of Oncology</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 PICCOLINO is a randomized health services study performed within the framework of the&#xD;
      Polish Colonoscopy Screening Program (PCSP) in Poland.&#xD;
&#xD;
      Within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from&#xD;
      the Population Registry and randomly assigned in a 1:1:1 ratio to receive an invitation to&#xD;
      participate in one of the three screening strategies: (I) postal invitation to colonoscopy&#xD;
      and a re-invitation to colonoscopy for initial non-responders, (II) postal invitation for&#xD;
      screening using fecal immunochemical test (FIT) for non-responders and subjects refusing a&#xD;
      colonoscopy, or (III) postal invitation offering a choice between FIT and colonoscopy.&#xD;
&#xD;
      Colonoscopies will be performed in seven local centers participating in the study. FITs will&#xD;
      be analyzed in the central laboratory. Subjects with positive FIT result will be recommended&#xD;
      to undergo colonoscopy.&#xD;
&#xD;
      The primary outcome is participation with CRC screening within 18 weeks after enrollment,&#xD;
      defined as completion of colonoscopy, or completion of FIT along with colonoscopy for&#xD;
      positive FIT result. Secondary outcome will be diagnostic yield for advanced neoplasia (CRC&#xD;
      or advanced adenoma). The study has been approved by a local bioethics committee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 25, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of the assigned screening strategy within 18 weeks of enrollment</measure>
    <time_frame>Within 18 weeks of enrollment</time_frame>
    <description>Completion of the assigned screening strategy within 18 weeks of enrollment defined as:&#xD;
current screening strategy: documented screening colonoscopy,&#xD;
sequential and multiple options strategies: documented colonoscopy, or receipt of FIT containing stool specimen. A positive FIT result requires subsequent documented colonoscopy to qualify as completed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield for CRC and advanced adenomas</measure>
    <time_frame>Within 18 weeks of enrollment</time_frame>
    <description>Advanced adenoma defined as adenoma &gt;1 cm in size, or with high-grade dysplasia, or with villous component (&gt;25%).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">12298</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Current screening practice.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects randomized into this group will receive named invitations for colonoscopy with pre-specified date, contact details of dedicated screening center. Invitations will be sent 6 weeks prior to suggested date of screening test. All subjects not responding to the invitation will receive a reminder letter 3 weeks prior to proposed appointment date. Additionally, a re-invitation for colonoscopy (screening test in 6 weeks) will be sent to participants not responding to the first invitation and the reminding letter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential screening strategy.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized into this group will be initially invited to participate in a screening colonoscopy as per group 1. All subjects who will refuse colonoscopy or do not respond to invitation within 6 weeks since the first letter, will receive another invitation letter with FIT test enclosed.&#xD;
The screening office will contact persons with a positive test result in order to determine the date of the colonoscopy appointment.&#xD;
A negative test result will be sent together with a recommendation to have another screening test performed 2 years later and information about the possible delivery of the test in two years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple options screening strategy.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive a letter with an offer to choose between colonoscopy or FIT screening.&#xD;
The first letter will include an invitation with a scheduled date of colonoscopy (in 6 weeks) and a FIT kit.&#xD;
Three weeks before a scheduled date of colonoscopy subjects randomized into this group will receive a reminder letter with an information about proposed screening methods. After the scheduled date of the colonoscopy examination, subjects who will not respond to the invitation for colonoscopy and will not send the FIT test back to the laboratory will receive another invitation for colonoscopy (in 6 weeks) and a FIT kit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Offering a choice for colorectal cancer screening</intervention_name>
    <description>Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.</description>
    <arm_group_label>Multiple options screening strategy.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Offering an alternative colorectal cancer screening method</intervention_name>
    <description>Persons randomized to the sequential screening strategy group will receive a postal invitation to the colonoscopy followed by a postal invitation for screening using FIT for non-responders and subjects refusing colonoscopy.</description>
    <arm_group_label>Sequential screening strategy.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Men and women aged 55 to 64 years residing in Poland and assigned to be invited to&#xD;
        screening within the Polish Colonoscopy Screening Program .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  information of a selected subject death informed by family, neighbors or post office&#xD;
             that has not been included in the Personal Identity Number (PESEL) system.&#xD;
&#xD;
          -  addressees of letters that have been returned by the post office.&#xD;
&#xD;
          -  subjects requiring long-term care due to somatic, psychosocial reasons or with mental&#xD;
             disability.&#xD;
&#xD;
          -  history of colorectal resection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michal Filip Kaminski, MD, PhD</last_name>
    <phone>+48 605438330</phone>
    <email>kaminski.mf@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nastazja Dagny Pilonis, MD</last_name>
    <phone>+48 510291110</phone>
    <email>nastazja@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maria Sklodowska-Curie Institute - Oncology Center</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michal Filip Kaminski, MD, PhD</last_name>
      <phone>+48 605438330</phone>
      <email>mfkaminski@coi.waw.pl</email>
    </contact>
    <contact_backup>
      <last_name>Nastazja Dagny Pilonis, MD</last_name>
      <phone>+48 510291110</phone>
      <email>nastazja@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maria Sklodowska-Curie National Research Institute of Oncology</investigator_affiliation>
    <investigator_full_name>Michal F. Kaminski, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Colorectal Cancer Screening</keyword>
  <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/NCT03790475
org study id: 43/PB/2018
nct id: NCT03790475
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The PICCOLINO is a randomized health services study performed within the framework of the
      Polish Colonoscopy Screening Program (PCSP) in Poland.

      Within the study 12,298 eligible persons between 55 and 64 years of age will be drawn from
      the Population Registry and randomly assigned in a 1:1:1 ratio to receive an invitation to
      participate in one of the three screening strategies: (I) postal invitation to colonoscopy
      and a re-invitation to colonoscopy for initial non-responders, (II) postal invitation for
      screening using fecal immunochemical test (FIT) for non-responders and subjects refusing a
      colonoscopy, or (III) postal invitation offering a choice between FIT and colonoscopy.

      Colonoscopies will be performed in seven local centers participating in the study. FITs will
      be analyzed in the central laboratory. Subjects with positive FIT result will be recommended
      to undergo colonoscopy.

      The primary outcome is participation with CRC screening within 18 weeks after enrollment,
      defined as completion of colonoscopy, or completion of FIT along with colonoscopy for
      positive FIT result. Secondary outcome will be diagnostic yield for advanced neoplasia (CRC
      or advanced adenoma). The study has been approved by a local bioethics committee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Completion of the assigned screening strategy within 18 weeks of enrollment
time frame: Within 18 weeks of enrollment
description: Completion of the assigned screening strategy within 18 weeks of enrollment defined as:
current screening strategy: documented screening colonoscopy,
sequential and multiple options strategies: documented colonoscopy, or receipt of FIT containing stool specimen. A positive FIT result requires subsequent documented colonoscopy to qualify as completed.
measure: Diagnostic yield for CRC and advanced adenomas
time frame: Within 18 weeks of enrollment
description: Advanced adenoma defined as adenoma >1 cm in size, or with high-grade dysplasia, or with villous component (>25%).
arm group label: Current screening practice.
arm group type: No Intervention
description: Subjects randomized into this group will receive named invitations for colonoscopy with pre-specified date, contact details of dedicated screening center. Invitations will be sent 6 weeks prior to suggested date of screening test. All subjects not responding to the invitation will receive a reminder letter 3 weeks prior to proposed appointment date. Additionally, a re-invitation for colonoscopy (screening test in 6 weeks) will be sent to participants not responding to the first invitation and the reminding letter.
arm group label: Sequential screening strategy.
arm group type: Experimental
description: Subjects randomized into this group will be initially invited to participate in a screening colonoscopy as per group 1. All subjects who will refuse colonoscopy or do not respond to invitation within 6 weeks since the first letter, will receive another invitation letter with FIT test enclosed.
The screening office will contact persons with a positive test result in order to determine the date of the colonoscopy appointment.
A negative test result will be sent together with a recommendation to have another screening test performed 2 years later and information about the possible delivery of the test in two years.
arm group label: Multiple options screening strategy.
arm group type: Experimental
description: Subjects in this group will receive a letter with an offer to choose between colonoscopy or FIT screening.
The first letter will include an invitation with a scheduled date of colonoscopy (in 6 weeks) and a FIT kit.
Three weeks before a scheduled date of colonoscopy subjects randomized into this group will receive a reminder letter with an information about proposed screening methods. After the scheduled date of the colonoscopy examination, subjects who will not respond to the invitation for colonoscopy and will not send the FIT test back to the laboratory will receive another invitation for colonoscopy (in 6 weeks) and a FIT kit.
intervention type: Other
intervention name: Offering a choice for colorectal cancer screening
description: Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
arm group label: Multiple options screening strategy.
intervention type: Other
intervention name: Offering an alternative colorectal cancer screening method
description: Persons randomized to the sequential screening strategy group will receive a postal invitation to the colonoscopy followed by a postal invitation for screening using FIT for non-responders and subjects refusing colonoscopy.
arm group label: Sequential screening strategy.
criteria: 
gender: All
minimum age: 55 Years
maximum age: 64 Years
healthy volunteers: No
last name: Michal Filip Kaminski, MD, PhD
phone: +48 605438330
email: kaminski.mf@gmail.com
last name: Nastazja Dagny Pilonis, MD
phone: +48 510291110
email: nastazja@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
investigator full name: Michal F. Kaminski, MD, PhD
investigator title: MD, PhD
mesh term: Colorectal Neoplasms