<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/NCT03227965</url>
  </required_header>
  <id_info>
    <org_study_id>ELITE</org_study_id>
    <nct_id>NCT03227965</nct_id>
  </id_info>
  <brief_title>Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation</brief_title>
  <official_title>Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer is a well known complication about long term transplantation. Cancer outcomes are due&#xD;
      to the immunosuppressive treatment that prevents transplanted people from rejection. By&#xD;
      lowering the effectiveness of the immune system, immune cells are no longer able to seek and&#xD;
      destroy cancer cells.&#xD;
&#xD;
      The goal here is to study immunes cells population of people that were transplanted 10 years&#xD;
      ago and are now treated either by a corticosteroid - azathioprine association, or only by&#xD;
      cyclosporine A.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immune cells study</measure>
    <time_frame>12 months</time_frame>
    <description>Study 2 types of T lymphocytes (by flow cytometry) that are suspected to be responsible of the graft non rejection and the cancer outcome, treated by corticosteroid - azathioprine association or cyclosporine A</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>bacteria study</measure>
    <time_frame>12 months</time_frame>
    <description>Study the modification of the intestinal bacteria population that might led to an &quot;operational tolerance&quot;, depending on the immunosuppressive treatment : the DNA will be extracted from the faeces and a typing will be carried out by Polymerase Chain Reaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cancer incidence</measure>
    <time_frame>12 months</time_frame>
    <description>Assess cancer incidence, on a population of people with kidney transplantation (since 10 years) : observation of adverse events during visits</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>ELITE</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Immune cells population assesment</intervention_name>
    <description>T lymphocytes population description through blood, urine and faeces samples</description>
    <arm_group_label>ELITE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18&#xD;
&#xD;
          -  Patients with kidney transplantation for 10 year&#xD;
&#xD;
          -  Patients with stable renal function (less than 20% creatinine variation during the&#xD;
             last 12 months)&#xD;
&#xD;
          -  Patients treated either by a corticosteroid - azathioprine association or cyclosporine&#xD;
             A&#xD;
&#xD;
          -  Patients giving his agreement&#xD;
&#xD;
          -  Patients legally free&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18&#xD;
&#xD;
          -  Patients under legal protection&#xD;
&#xD;
          -  Pregnant women, or of age to get pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>April 24, 2019</last_update_submitted>
  <last_update_submitted_qc>April 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <!-- 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/NCT03227965
org study id: ELITE
nct id: NCT03227965
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cancer is a well known complication about long term transplantation. Cancer outcomes are due
      to the immunosuppressive treatment that prevents transplanted people from rejection. By
      lowering the effectiveness of the immune system, immune cells are no longer able to seek and
      destroy cancer cells.

      The goal here is to study immunes cells population of people that were transplanted 10 years
      ago and are now treated either by a corticosteroid - azathioprine association, or only by
      cyclosporine A.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Immune cells study
time frame: 12 months
description: Study 2 types of T lymphocytes (by flow cytometry) that are suspected to be responsible of the graft non rejection and the cancer outcome, treated by corticosteroid - azathioprine association or cyclosporine A
measure: bacteria study
time frame: 12 months
description: Study the modification of the intestinal bacteria population that might led to an "operational tolerance", depending on the immunosuppressive treatment : the DNA will be extracted from the faeces and a typing will be carried out by Polymerase Chain Reaction
measure: cancer incidence
time frame: 12 months
description: Assess cancer incidence, on a population of people with kidney transplantation (since 10 years) : observation of adverse events during visits
arm group label: ELITE
arm group type: Other
intervention type: Biological
intervention name: Immune cells population assesment
description: T lymphocytes population description through blood, urine and faeces samples
arm group label: ELITE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor