<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/NCT03305302</url>
  </required_header>
  <id_info>
    <org_study_id>ZWETYENGA 2017</org_study_id>
    <nct_id>NCT03305302</nct_id>
  </id_info>
  <brief_title>Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL</brief_title>
  <official_title>Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      In terms of incidence, cancer of the tongue is one of the leading cancers in France.&#xD;
      Moreover, this cancer is associated with physiological complications ranging from swallowing&#xD;
      disorders to loss of taste. Following surgery, impaired perception of food taste may lead to&#xD;
      cachexia. It is therefore necessary to carry out research in the field of impaired taste,&#xD;
      notably with regard to the regeneration of taste buds. However, there is currently no&#xD;
      available functional model of taste bud cells.&#xD;
&#xD;
      It is therefore necessary to obtain a cell line of human taste cells. These immortalised&#xD;
      human cells will allow us to better orient our investigations for applications in humans:&#xD;
      search for and characterisation of &quot;taste modifiers&quot; synthesised using organic chemistry,&#xD;
      able to trigger the perception of food in cases of taste loss or taste impairment.&#xD;
&#xD;
      Moreover, given recent studies conducted by the investigating team proposing the existence of&#xD;
      a fatty taste and its implication in obesity, the work of the team could be oriented towards&#xD;
      the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of&#xD;
      sugar. The availability of these chemical molecules would lead to a reduction in lipid intake&#xD;
      as these agents contain no (or very few) calories. They will act as an organoleptic decoy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immortalised human taste bud cells, isolated from the fungiform tastebuds of patients with cancer of the mobile tongue.</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Cancer of the Tongue</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sample of cancerous epithelium from the tongue</intervention_name>
    <description>Harvesting and culture of cancerous epithelium from the surgical piece</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18 and 70 years old,&#xD;
&#xD;
          -  with cancer of the mobile tongue&#xD;
&#xD;
          -  requiring surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - chronic smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</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>Tongue 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/NCT03305302
org study id: ZWETYENGA 2017
nct id: NCT03305302
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In terms of incidence, cancer of the tongue is one of the leading cancers in France.
      Moreover, this cancer is associated with physiological complications ranging from swallowing
      disorders to loss of taste. Following surgery, impaired perception of food taste may lead to
      cachexia. It is therefore necessary to carry out research in the field of impaired taste,
      notably with regard to the regeneration of taste buds. However, there is currently no
      available functional model of taste bud cells.

      It is therefore necessary to obtain a cell line of human taste cells. These immortalised
      human cells will allow us to better orient our investigations for applications in humans:
      search for and characterisation of "taste modifiers" synthesised using organic chemistry,
      able to trigger the perception of food in cases of taste loss or taste impairment.

      Moreover, given recent studies conducted by the investigating team proposing the existence of
      a fatty taste and its implication in obesity, the work of the team could be oriented towards
      the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of
      sugar. The availability of these chemical molecules would lead to a reduction in lipid intake
      as these agents contain no (or very few) calories. They will act as an organoleptic decoy.
observational model: Case-Only
time perspective: Prospective
measure: Immortalised human taste bud cells, isolated from the fungiform tastebuds of patients with cancer of the mobile tongue.
time frame: through study completion, an average of 1 year
intervention type: Procedure
intervention name: Sample of cancerous epithelium from the tongue
description: Harvesting and culture of cancerous epithelium from the surgical piece
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Tongue Neoplasms