<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/NCT03017573</url>
  </required_header>
  <id_info>
    <org_study_id>IC 2016-03</org_study_id>
    <nct_id>NCT03017573</nct_id>
  </id_info>
  <brief_title>Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)</brief_title>
  <acronym>SCANDARE</acronym>
  <official_title>Prospective Biobanking Study in Ovarian, Breast, Head and Neck and Cervical Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)</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>
      SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at&#xD;
      different time points in ovarian, triple negative breast, Head and Neck Cancer and Cervical&#xD;
      cancer patients. This study will allowed to identify new molecular and/or immunological&#xD;
      biomarkers associated with clinical and biological features of the tumors. All patients will&#xD;
      receive standard treatment according to the stage of the diseases and usual procédures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will have blood and +/- tumor samples at the following times :&#xD;
&#xD;
        1. if eligible for surgery :&#xD;
&#xD;
             -  at surgery (blood + tumor and nodes)&#xD;
&#xD;
             -  after surgery (blood)&#xD;
&#xD;
             -  6 months after surgery if non recurrence (Blood)&#xD;
&#xD;
             -  before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor&#xD;
                biopsie and nodes if possible)&#xD;
&#xD;
             -  before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)&#xD;
&#xD;
             -  at progression (blood + tumor biopsie and nodes if possible)&#xD;
&#xD;
        2. if eligible for neoadjuvant chemotherapy :&#xD;
&#xD;
             -  before neoadjuvant therapy (blood + tumor biopsie and nodes)&#xD;
&#xD;
             -  during neoadjuvant therapy (post cycle 1) (blood)&#xD;
&#xD;
             -  at the time of surgery (blood + tumor and nodes)&#xD;
&#xD;
             -  6 months after surgery if non recurrence (Blood)&#xD;
&#xD;
             -  before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor&#xD;
                biopsie and nodes)&#xD;
&#xD;
             -  before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)&#xD;
&#xD;
             -  at progression (blood + tumor biopsie and nodes)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Anticipated">January 6, 2031</completion_date>
  <primary_completion_date type="Anticipated">August 2028</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between tumor molecular/immunological profile and Baseline clinicobiological features</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between disease recurrence and molecular and/or immunological biomarkers</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between genomic alterations and immune parameters</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between mutations load and immune parameters</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between ctDNA levels, de novo mutations in ctDNA and immune</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Triple-Negative Breast Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Tumor and blood sampling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have a biopsy or a surgery and blood sampling at different time points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tumor biopsies / Tumor surgery</intervention_name>
    <description>Tumoral tissues samples must be collected at different times points :&#xD;
at the time of surgery&#xD;
before first cycle of adjuvant treatment (if possible)&#xD;
at progression (if possible)&#xD;
OR&#xD;
before neoadjuvant therapy&#xD;
at the time of surgery&#xD;
before first cycle of adjuvant treatment (if possible)&#xD;
at progression (if possible)</description>
    <arm_group_label>Tumor and blood sampling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood withdrawal</intervention_name>
    <description>Blood samples must be collected at different times points :&#xD;
at the time of surgery or before the beginning of chemoradiotherapy&#xD;
after surgery or after chemoradiotherapy&#xD;
6 months after surgery if non recurrence&#xD;
before first cycle of adjuvant treatment or before radiotherapy&#xD;
before second cycle of adjuvant treatment or after radiotherapy&#xD;
at progression&#xD;
OR&#xD;
before neoadjuvant therapy&#xD;
during neoadjuvant therapy (post cycle 1)&#xD;
at the time of surgery&#xD;
6 months after surgery if non recurrence&#xD;
before first cycle of adjuvant treatment or before radiotherapy&#xD;
before second cycle of adjuvant treatment or after radiotherapy&#xD;
at progression</description>
    <arm_group_label>Tumor and blood sampling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Tumor types :&#xD;
&#xD;
               1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or&#xD;
                  neoadjuvant chemotherapy&#xD;
&#xD;
               2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible&#xD;
                  for surgery or neoadjuvant chemotherapy&#xD;
&#xD;
               3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for&#xD;
                  surgery&#xD;
&#xD;
               4. Newly diagnosed treatment-naïve cervical cancer patients (1) stage Ia - IIa1 with&#xD;
                  nodal metastasis, postoperative positive margin or parametrial-vaginal&#xD;
                  involvement, and (2) stage ≥IIa2).&#xD;
&#xD;
          2. Male or female patients ≥ 18 years of age&#xD;
&#xD;
          3. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male or female patients ≤18 years old&#xD;
&#xD;
          2. Patients with any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule&#xD;
&#xD;
          3. Individually deprived of liberty or placed under the authority of a tutor&#xD;
&#xD;
          4. Patients not affiliated to the Social Security System&#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>Christophe LE TOURNEAU, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Curie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne-Sophie PLISSONNIER</last_name>
    <phone>01 47 11 23 78</phone>
    <email>drci.promotion@curie.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Frédéric GUYON, MD</last_name>
      <email>f.guyon@unicancer.bordeaux.fr</email>
    </contact>
    <investigator>
      <last_name>Frédéric GUYON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Camille PASQUESOONE, MD</last_name>
      <email>c.pasquesoone@o-lambret.fr</email>
    </contact>
    <investigator>
      <last_name>Camille PASQUESOONE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicolas CHOPIN, MD</last_name>
    </contact>
    <contact_backup>
      <email>nicolas.chopin@lyon.unicancer.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Nicolas CHOPIN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe LE TOURNEAU, MD</last_name>
      <email>christophe.letourneau@curie.fr</email>
    </contact>
    <investigator>
      <last_name>Christophe LE TOURNEAU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Curie Hopital Rene Huguenin</name>
      <address>
        <city>Saint-cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas POUGET, MD</last_name>
      <email>nicolas.pouget@curie.fr</email>
    </contact>
    <investigator>
      <last_name>Nicolas POUGET, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunological biomarkers</keyword>
  <keyword>molecular profil</keyword>
  <keyword>Circulating tumor DNA (ctDNA)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Triple Negative 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/NCT03017573
org study id: IC 2016-03
nct id: NCT03017573
lead sponsor: 
has dmc: No
SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at
      different time points in ovarian, triple negative breast, Head and Neck Cancer and Cervical
      cancer patients. This study will allowed to identify new molecular and/or immunological
      biomarkers associated with clinical and biological features of the tumors. All patients will
      receive standard treatment according to the stage of the diseases and usual procédures.
Patients will have blood and +/- tumor samples at the following times :

        1. if eligible for surgery :

             -  at surgery (blood + tumor and nodes)

             -  after surgery (blood)

             -  6 months after surgery if non recurrence (Blood)

             -  before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor
                biopsie and nodes if possible)

             -  before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)

             -  at progression (blood + tumor biopsie and nodes if possible)

        2. if eligible for neoadjuvant chemotherapy :

             -  before neoadjuvant therapy (blood + tumor biopsie and nodes)

             -  during neoadjuvant therapy (post cycle 1) (blood)

             -  at the time of surgery (blood + tumor and nodes)

             -  6 months after surgery if non recurrence (Blood)

             -  before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor
                biopsie and nodes)

             -  before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)

             -  at progression (blood + tumor biopsie and nodes)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Correlation between tumor molecular/immunological profile and Baseline clinicobiological features
time frame: up to 6 months
measure: Correlation between disease recurrence and molecular and/or immunological biomarkers
time frame: up to 24 months
measure: Correlation between genomic alterations and immune parameters
time frame: up to 24 months
measure: Correlation between mutations load and immune parameters
time frame: up to 24 months
measure: Correlation between ctDNA levels, de novo mutations in ctDNA and immune
time frame: up to 24 months
measure: For cervical cancer patient, correlation between ctDNA levels and kinetics, and prognosis, prediction of recurrence
time frame: up to 24 months
arm group label: Tumor and blood sampling
arm group type: Experimental
description: Patients will have a biopsy or a surgery and blood sampling at different time points.
intervention type: Procedure
intervention name: Tumor biopsies / Tumor surgery
description: Tumoral tissues samples must be collected at different times points :
at the time of surgery
before first cycle of adjuvant treatment (if possible)
at progression (if possible)
OR
before neoadjuvant therapy
at the time of surgery
before first cycle of adjuvant treatment (if possible)
at progression (if possible)
arm group label: Tumor and blood sampling
intervention type: Procedure
intervention name: Blood withdrawal
description: Blood samples must be collected at different times points :
at the time of surgery or before the beginning of chemoradiotherapy
after surgery or after chemoradiotherapy
6 months after surgery if non recurrence
before first cycle of adjuvant treatment or before radiotherapy
before second cycle of adjuvant treatment or after radiotherapy
at progression
OR
before neoadjuvant therapy
during neoadjuvant therapy (post cycle 1)
at the time of surgery
6 months after surgery if non recurrence
before first cycle of adjuvant treatment or before radiotherapy
before second cycle of adjuvant treatment or after radiotherapy
at progression
arm group label: Tumor and blood sampling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christophe LE TOURNEAU, Prof.
role: Principal Investigator
affiliation: Institut Curie
last name: Anne-Sophie PLISSONNIER
phone: 01 47 11 23 78
email: drci.promotion@curie.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms
mesh term: Triple Negative Breast Neoplasms
sharing ipd: No