<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/NCT03015038</url>
  </required_header>
  <id_info>
    <org_study_id>C16-21</org_study_id>
    <secondary_id>2016-A01102-49</secondary_id>
    <nct_id>NCT03015038</nct_id>
  </id_info>
  <brief_title>Study of the Immune Response in Colon Adenocarcinoma</brief_title>
  <acronym>IMCO</acronym>
  <official_title>Etude de la réponse Immunitaire Dans l'adénocarcinome Colique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innate Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Duration of each part of the study per patient:&#xD;
&#xD;
        -  Screening: From 1 to 4 weeks&#xD;
&#xD;
        -  Sampling period (blood and tissue): 1 day&#xD;
&#xD;
        -  Follow-up by patient: 60 months&#xD;
&#xD;
        -  Total study duration by patient: 84 months&#xD;
&#xD;
        -  Total inclusion duration: 24 months&#xD;
&#xD;
        -  Total Follow-up duration: 60 months&#xD;
&#xD;
        -  Total study duration: 84 months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 5, 2017</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immune cells trafficking</measure>
    <time_frame>Day 0</time_frame>
    <description>Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infiltration of leucocytes in tumor tissue</measure>
    <time_frame>Day 0</time_frame>
    <description>Histochemical method with a panel of Ab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety (Number of adverse events, ECOG status)</measure>
    <time_frame>After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colon Adenocarcinoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tissu and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with colon adenocarcinoma treated by surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 18 or more.&#xD;
&#xD;
          2. Affiliation to a social security scheme&#xD;
&#xD;
          3. Diagnosis of a colon adenocarcinoma.&#xD;
&#xD;
          4. Patient have signed and dated consent of the study before undertaking procedures&#xD;
             related to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients under guardianship / curatorship&#xD;
&#xD;
          2. Following Situations&#xD;
&#xD;
               -  Persons unable to understand, read and / or sign an informed consent&#xD;
&#xD;
               -  Patient with the following functions: investigator or co-investigator, research&#xD;
                  assistant, pharmacist, study coordinator or having any involvement in the study&#xD;
&#xD;
               -  Uncooperative person or potentially non-compliant for the study and its&#xD;
                  procedures with predictable difficulties regular monitoring of over 1 year.&#xD;
&#xD;
               -  No affiliation to a social security scheme, a universal medical coverage or any&#xD;
                  similar plan.&#xD;
&#xD;
          3. Pregnant or lactating women.&#xD;
&#xD;
          4. Patients with HIV seropositivity.&#xD;
&#xD;
          5. Rectal tumor location.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthieu Allez, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Saint Louis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</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>Adenocarcinoma</mesh_term>
    <mesh_term>Colonic 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>


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/NCT03015038
org study id: C16-21
secondary id: 2016-A01102-49
nct id: NCT03015038
lead sponsor: 
collaborator: 
has dmc: No
Duration of each part of the study per patient:

        -  Screening: From 1 to 4 weeks

        -  Sampling period (blood and tissue): 1 day

        -  Follow-up by patient: 60 months

        -  Total study duration by patient: 84 months

        -  Total inclusion duration: 24 months

        -  Total Follow-up duration: 60 months

        -  Total study duration: 84 months
observational model: Cohort
time perspective: Prospective
measure: Immune cells trafficking
time frame: Day 0
description: Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).
measure: Infiltration of leucocytes in tumor tissue
time frame: Day 0
description: Histochemical method with a panel of Ab.
measure: Safety (Number of adverse events, ECOG status)
time frame: After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)
Tissu and blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthieu Allez, MD, PhD
role: Principal Investigator
affiliation: Hopital Saint Louis
facility: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Colonic Neoplasms
sharing ipd: No