<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/NCT03798977</url>
  </required_header>
  <id_info>
    <org_study_id>17-PRTK-01</org_study_id>
    <nct_id>NCT03798977</nct_id>
  </id_info>
  <brief_title>Preclinical Validation of New Anti-melanoma Compounds</brief_title>
  <acronym>ERMELATHER</acronym>
  <official_title>Preclinical Validation of New Anti-melanoma Compounds: Study on Patient Melanoma Cells Sensitive and Resistant to BRAF/MEK Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      This research program is in keeping with the chemistry/biology/clinical interface and gathers&#xD;
      4 teams with complementary expertise in these respective fields. It will allow deciphering&#xD;
      the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on&#xD;
      metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will&#xD;
      use melanoma cell lines and primary cells from patients to validate these compounds in&#xD;
      collaboration with clinical team 2 and 4. In conclusion, the investigators expect to&#xD;
      establish the proof of concept that this new class of bioactive molecules (first in class) we&#xD;
      developed in collaboration with Team 3 have the potential to go to the clinic for the&#xD;
      treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and&#xD;
      resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can&#xD;
      undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in&#xD;
      resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of&#xD;
      restoring the sensitivity of these melanoma cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>BRAF mutation</measure>
    <time_frame>24 months</time_frame>
    <description>The status of the BRAF mutation will be expressed through laboratory analysis of the samples collected, i.e. positive or negative.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Melanoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      biopsy of a target lesion (skin, lymph node or visceral metastases)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with metastatic melanoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with metastatic melanoma&#xD;
&#xD;
          -  Not opposition of the patient will have been looked for&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary resistance,&#xD;
&#xD;
          -  Absence of resistance,&#xD;
&#xD;
          -  Patient already included in other trials&#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_contact>
    <last_name>Thierry PASSERON, Pr</last_name>
    <phone>492036488</phone>
    <phone_ext>+33</phone_ext>
    <email>passeron.t@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Henri MONTAUDIE, Dr</last_name>
    <phone>492036083</phone>
    <phone_ext>+33</phone_ext>
    <email>montaudie.h@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nice hospital</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry Passeron, Pr</last_name>
      <phone>492036488</phone>
      <phone_ext>33</phone_ext>
      <email>passeron.t@chu-nice.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin metastasis</keyword>
  <keyword>Resistance</keyword>
  <keyword>Endoplasmic reticulum stress</keyword>
  <keyword>Metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03798977
org study id: 17-PRTK-01
nct id: NCT03798977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research program is in keeping with the chemistry/biology/clinical interface and gathers
      4 teams with complementary expertise in these respective fields. It will allow deciphering
      the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on
      metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will
      use melanoma cell lines and primary cells from patients to validate these compounds in
      collaboration with clinical team 2 and 4. In conclusion, the investigators expect to
      establish the proof of concept that this new class of bioactive molecules (first in class) we
      developed in collaboration with Team 3 have the potential to go to the clinic for the
      treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and
      resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can
      undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in
      resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of
      restoring the sensitivity of these melanoma cells.
observational model: Other
time perspective: Cross-Sectional
measure: BRAF mutation
time frame: 24 months
description: The status of the BRAF mutation will be expressed through laboratory analysis of the samples collected, i.e. positive or negative.
biopsy of a target lesion (skin, lymph node or visceral metastases)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thierry PASSERON, Pr
phone: 492036488
phone ext: +33
email: passeron.t@chu-nice.fr
last name: Henri MONTAUDIE, Dr
phone: 492036083
phone ext: +33
email: montaudie.h@chu-nice.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Melanoma
sharing ipd: Undecided