<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/NCT03255486</url>
  </required_header>
  <id_info>
    <org_study_id>ICM2013/12</org_study_id>
    <nct_id>NCT03255486</nct_id>
  </id_info>
  <brief_title>Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy (IDEA SEIN)</brief_title>
  <acronym>IDEASEIN</acronym>
  <official_title>Identification and Evaluation of Biomarkers of Resistance to Neoadjuvant Chemotherapy and Establishment of Preclinical Models of Resistance in Locally Advanced Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and&#xD;
      establishment of preclinical models of resistance in locally advanced breast cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>predictive molecular abnormalities assessment</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Blood sample</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.&#xD;
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.&#xD;
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).</description>
    <arm_group_label>Blood sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  proven invasive breast adenocarcinoma (cytology and / or biopsy).&#xD;
&#xD;
               -  locally advanced stage (tumor size greater than 2 cm).&#xD;
&#xD;
               -  neoadjuvant chemotherapy indication validated RCP&#xD;
&#xD;
               -  Patient eligible for neoadjuvant chemotherapy.&#xD;
&#xD;
               -  Performance Index according to WHO or less 1.&#xD;
&#xD;
               -  Patient aged 18 years and older.&#xD;
&#xD;
               -  Being affiliated to a social security scheme or an equivalent scheme of social&#xD;
                  protection&#xD;
&#xD;
               -  Obtaining signed informed consent, and that before any specific prequalification&#xD;
                  testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of metastatic disease at diagnosis.&#xD;
&#xD;
               -  Breast Cancer inflammatory.&#xD;
&#xD;
               -  rare histologic subtypes (non ductal lobular and not).&#xD;
&#xD;
               -  Other cancer (except basal cell skin carcinoma and cancer of the cervix in situ&#xD;
                  adequately treated and curative) treated in the previous 5 years.&#xD;
&#xD;
               -  Patient pregnant or nursing or of childbearing age without effective&#xD;
                  contraception.&#xD;
&#xD;
               -  Breast cancer in men.&#xD;
&#xD;
               -  legal incapacity or limited legal capacity. medical or psychological conditions&#xD;
                  allowing the subject to complete the study or to sign the consent (art. L.1121-6,&#xD;
                  L.1121-7, L.1211-8, L1211-9).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Ychou</last_name>
    <role>Study Director</role>
    <affiliation>Institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut régional du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</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>Breast Neoplasms</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/NCT03255486
org study id: ICM2013/12
nct id: NCT03255486
lead sponsor: 
has dmc: No
Biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
Identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and
      establishment of preclinical models of resistance in locally advanced breast cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: predictive molecular abnormalities assessment
time frame: up to 5 years
description: Highlighting and study of predictive molecular abnormalities of resistance to neoadjuvant chemotherapy in locally advanced breast cancer
arm group label: Blood sample
arm group type: Experimental
description: Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).
intervention type: Biological
intervention name: Blood sample
description: Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study).
arm group label: Blood sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Ychou
role: Study Director
affiliation: Institut régional du Cancer de Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No