<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/NCT03775473</url>
  </required_header>
  <id_info>
    <org_study_id>PROCODE</org_study_id>
    <nct_id>NCT03775473</nct_id>
  </id_info>
  <brief_title>PROgastrine COlon DEpistage</brief_title>
  <official_title>Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ECS-Progastrin SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Princesse Grace</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ECS-Progastrin SA</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>
      Dosage of progastrin in asymptomatic person participating in colon cancer screening&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For anyone who will participate in colon screening at the Princess Grace Hospital of Monaco&#xD;
      and who has signed the informed consent document. A blood test will be performed in addition&#xD;
      to the screening test to assess the rate of progastrin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 pandemic has made it increasingly difficult for ECS progastrin to ensure clinical&#xD;
    research is maintained.&#xD;
&#xD;
    As a result, the sponsor made the decision to end patient enrollment prematurely.&#xD;
  </why_stopped>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Interventional Research, at Risk and Minimal Constraints, Category 2</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progastrin rate</measure>
    <time_frame>from 15 days to 2 months (until results are obtained)</time_frame>
    <description>measuring the rate of progastrin in the blood</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Colon Cancer Screening</condition>
  <condition>Healthy Person</condition>
  <arm_group>
    <arm_group_label>progastrin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>progastrin</intervention_name>
    <description>PROCODE is an interventional study of category 2 (non-medicinal product), with a minimal risks and restrictions, involving only one blood drawn at the screening of colon cancer.</description>
    <arm_group_label>progastrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participant in colon cancer screening&#xD;
&#xD;
          -  signing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any major medical, psychiatric or addictive illness that would affect the informed&#xD;
             consent process&#xD;
&#xD;
          -  The consent of a representative is not allowed in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georges GARNIER</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Princesse Grace</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Princesse Grace, Monaco</name>
      <address>
        <city>Montpellier</city>
        <state>MC</state>
        <zip>34070 MONTPELLIER</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>January 12, 2022</last_update_submitted>
  <last_update_submitted_qc>January 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>progastrin</keyword>
  <keyword>screening</keyword>
  <keyword>bio-marker</keyword>
  <keyword>healthy person</keyword>
  <keyword>early stage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Monocentric study; No IPD sharing</ipd_description>
  </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/NCT03775473
org study id: PROCODE
nct id: NCT03775473
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dosage of progastrin in asymptomatic person participating in colon cancer screening
For anyone who will participate in colon screening at the Princess Grace Hospital of Monaco
      and who has signed the informed consent document. A blood test will be performed in addition
      to the screening test to assess the rate of progastrin.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Interventional Research, at Risk and Minimal Constraints, Category 2
primary purpose: Diagnostic
masking: None (Open Label)
measure: progastrin rate
time frame: from 15 days to 2 months (until results are obtained)
description: measuring the rate of progastrin in the blood
arm group label: progastrin
arm group type: Other
description: anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document
intervention type: Diagnostic Test
intervention name: progastrin
description: PROCODE is an interventional study of category 2 (non-medicinal product), with a minimal risks and restrictions, involving only one blood drawn at the screening of colon cancer.
arm group label: progastrin
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Georges GARNIER
role: Principal Investigator
affiliation: Centre Hospitalier Princesse Grace
facility: 
country: France
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: No
ipd description: Monocentric study; No IPD sharing