<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/NCT03797053</url>
  </required_header>
  <id_info>
    <org_study_id>NI15009</org_study_id>
    <nct_id>NCT03797053</nct_id>
  </id_info>
  <brief_title>Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology</brief_title>
  <acronym>EXPEVIVO-CTC</acronym>
  <official_title>Expansion ex Vivo Des Cellules Tumorales Circulantes Comme modèle de Pharmacologie prédictive Des Cancers. EXPEVIVO-CTC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ScreenCell</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Celenys</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imstar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs)&#xD;
      can be used as a marker for predicting disease progression and survival in patients with&#xD;
      early or metastatic cancer. A high number of CTCs correlate with aggressive disease,&#xD;
      increased metastasis and decreased survival rates.&#xD;
&#xD;
      Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after&#xD;
      orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to&#xD;
      carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because&#xD;
      circulating blood collection is simple and non-invasive, CTCs can be used as a marker to&#xD;
      track disease progression and survival in real time. CTCs could also guide therapeutic&#xD;
      choice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 6, 2015</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</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>Therapeutical response</measure>
    <time_frame>6 months</time_frame>
    <description>Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free Survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free Survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free Survival</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Melanoma</condition>
  <condition>Circulating Tumor Cell</condition>
  <arm_group>
    <arm_group_label>Cohort 1 : metastatic cohort</arm_group_label>
    <description>Cohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 : adjuvant cohort</arm_group_label>
    <description>Cohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis.&#xD;
This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biological sample</intervention_name>
    <description>Biological sample performed :&#xD;
before treatment&#xD;
1 months after the beginning of treatment&#xD;
every tumoral assessment</description>
    <arm_group_label>Cohort 1 : metastatic cohort</arm_group_label>
    <arm_group_label>Cohort 2 : adjuvant cohort</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort1: Cohort of patients with stage III unresectable or IV metastatic melanoma patients&#xD;
        Cohort 2: Cohort of patients with melanoma candidates for sentinel lymph node analysis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        COHORT 1&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed cutaneous or mucosal melanoma (per American joint committee&#xD;
             on cancer (AJCC) staging system) that is unresectable or metastatic&#xD;
&#xD;
          -  No prior systemic anticancer therapy for unresectable/metastatic melanoma or&#xD;
             clinical/radiological disease progression (RECIST1.1) if previously treated and before&#xD;
             new treatment&#xD;
&#xD;
          -  No prior malignancy active within the previous 3 years except for locally curable&#xD;
             cancers that have been apparently cured, such as cutaneous carcinoma or cervix)&#xD;
&#xD;
          -  followed in Saint Louis Hospital&#xD;
&#xD;
          -  Tumor tissue available in Saint Louis Hospital&#xD;
&#xD;
          -  Subjects must have signed and approved written informed consent form&#xD;
&#xD;
          -  No pregnancy&#xD;
&#xD;
          -  Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus&#xD;
             indicating acute or chronic infection, and/or detectable virus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
&#xD;
        COHORT 2 :&#xD;
&#xD;
        Inclusion Criteria :&#xD;
&#xD;
          -  Histologically confirmed cutaneous or mucosal melanoma&#xD;
&#xD;
          -  Candidates for sentinel lymph node analysis and surgical recovery (this examination is&#xD;
             in practice reserved for melanomas &gt;1mm thick or ulcerated)&#xD;
&#xD;
          -  No prior adjuvant anticancer therapy&#xD;
&#xD;
          -  followed in Saint Louis Hospital&#xD;
&#xD;
          -  Tumor tissue available in Saint Louis Hospital&#xD;
&#xD;
          -  Subjects must have signed and approved written informed consent form&#xD;
&#xD;
          -  No pregnancy&#xD;
&#xD;
          -  Any positive test for hepatitis A virus, hepatitis B virus or hepatitis C virus&#xD;
             indicating acute or chronic infection, and/or detectable virus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Celeste Lebbe, MD PhD</last_name>
    <phone>142499590</phone>
    <phone_ext>+33</phone_ext>
    <email>celeste.lebbe@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu RESCHE-RIGON, MD PhD</last_name>
    <phone>142499742</phone>
    <phone_ext>+33</phone_ext>
    <email>matthieu.resche-rigon@univ-paris-diderot.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Saint-Louis Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Celeste Lebbe, MD PhD</last_name>
      <phone>142499590</phone>
      <phone_ext>+33</phone_ext>
      <email>celeste.lebbe@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>laetitia Da Meda</last_name>
      <phone>142499392</phone>
      <phone_ext>+33</phone_ext>
      <email>laetitia.da-meda@aphp.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>March 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</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>Neoplastic Cells, Circulating</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/NCT03797053
org study id: NI15009
nct id: NCT03797053
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs)
      can be used as a marker for predicting disease progression and survival in patients with
      early or metastatic cancer. A high number of CTCs correlate with aggressive disease,
      increased metastasis and decreased survival rates.

      Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after
      orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to
      carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because
      circulating blood collection is simple and non-invasive, CTCs can be used as a marker to
      track disease progression and survival in real time. CTCs could also guide therapeutic
      choice.
observational model: Cohort
time perspective: Prospective
measure: Therapeutical response
time frame: 6 months
description: Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria.
measure: Survival
time frame: 1 year
measure: Survival
time frame: 3 years
measure: Survival
time frame: 5 years
measure: Disease free Survival
time frame: 1 year
measure: Disease free Survival
time frame: 3 years
measure: Disease free Survival
time frame: 5 years
arm group label: Cohort 1 : metastatic cohort
description: Cohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value).
arm group label: Cohort 2 : adjuvant cohort
description: Cohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis.
This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis).
intervention type: Procedure
intervention name: Biological sample
description: Biological sample performed :
before treatment
1 months after the beginning of treatment
every tumoral assessment
arm group label: Cohort 1 : metastatic cohort
arm group label: Cohort 2 : adjuvant cohort
Blood Sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Celeste Lebbe, MD PhD
phone: 142499590
phone ext: +33
email: celeste.lebbe@aphp.fr
last name: Matthieu RESCHE-RIGON, MD PhD
phone: 142499742
phone ext: +33
email: matthieu.resche-rigon@univ-paris-diderot.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Neoplastic Cells, Circulating
sharing ipd: No