<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/NCT02220556</url>
  </required_header>
  <id_info>
    <org_study_id>IC 2010-01</org_study_id>
    <nct_id>NCT02220556</nct_id>
  </id_info>
  <brief_title>Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology</brief_title>
  <acronym>CTC-CEC-ADN</acronym>
  <official_title>Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Curie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Curie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral&#xD;
      type. Up to 50 patient can be included into each cohort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2010</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CTC, CEC or ctDNA incidence</measure>
    <time_frame>3 years</time_frame>
    <description>number of CTC or CEC in 7.5ml of blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CTC and CEC molecular characterization</measure>
    <time_frame>3 years</time_frame>
    <description>This outcome is self-explanatory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating tumor DNA (ctDNA) detection and quantification</measure>
    <time_frame>3 years</time_frame>
    <description>plasma mutation detection (number of copy)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Solid Tumor.</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or more&#xD;
&#xD;
          -  Performance status from 0 to 4&#xD;
&#xD;
          -  Patient treated followed for histologically confirmed solid tumor type of any of these&#xD;
             localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma.&#xD;
&#xD;
          -  Informed consent form signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with history of other invasive cancer within 5 years.&#xD;
&#xD;
          -  Patient treated for any non-invasive cancer&#xD;
&#xD;
          -  Patient individually deprived of liberty or placed under the authority of a tutor&#xD;
&#xD;
          -  Geographical condition potentially preventing compliance with the study protocol.&#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>Jean-Yves Pierga, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Curie</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François-Clément Bidard, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institut Curie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patricia Tresca, MD</last_name>
    <phone>+33 (0) 1 56.24.57.65</phone>
    <email>patricia.tresca@curie.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jean-Yves Pierga, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>François-Clément Bidard, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christophe Louvet, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Emmanuel Mitry, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>July 6, 2016</last_update_submitted>
  <last_update_submitted_qc>July 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 7, 2016</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>
  <!-- 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/NCT02220556
org study id: IC 2010-01
nct id: NCT02220556
lead sponsor: 
has dmc: No
Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral
      type. Up to 50 patient can be included into each cohort.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: CTC, CEC or ctDNA incidence
time frame: 3 years
description: number of CTC or CEC in 7.5ml of blood
measure: CTC and CEC molecular characterization
time frame: 3 years
description: This outcome is self-explanatory.
measure: Circulating tumor DNA (ctDNA) detection and quantification
time frame: 3 years
description: plasma mutation detection (number of copy)
intervention type: Procedure
intervention name: Blood sampling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Yves Pierga, Prof.
role: Principal Investigator
affiliation: Institut Curie
last name: François-Clément Bidard, MD, PhD
role: Study Chair
affiliation: Institut Curie
last name: Patricia Tresca, MD
phone: +33 (0) 1 56.24.57.65
email: patricia.tresca@curie.fr
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
mesh term: Neoplastic Cells, Circulating