<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/NCT03831230</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02152-53</org_study_id>
    <nct_id>NCT03831230</nct_id>
  </id_info>
  <brief_title>Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response</brief_title>
  <acronym>OVAREX</acronym>
  <official_title>Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Francois Baclesse</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>
      Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 7, 2019</start_date>
  <completion_date type="Anticipated">August 2029</completion_date>
  <primary_completion_date type="Anticipated">August 2024</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>Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests</measure>
    <time_frame>Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery</time_frame>
    <description>Number and quality of tumor, blood and urine samples that can be used to perform predictive tests of the response to treatment</description>
  </primary_outcome>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Ovarian Cancer</condition>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>collection of blood, urine, tumor and ascite samples</intervention_name>
    <description>collection of blood, urine, tumor and ascite samples during ovarian surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven&#xD;
        peritoneum. All FIGO stages are accepted for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years old.&#xD;
&#xD;
          -  Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically&#xD;
             proven peritoneum. All FIGO stages are accepted for the study.&#xD;
&#xD;
          -  Patient to be managed by surgery (laparoscopy and / or laparotomy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Persons deprived of liberty or guardianship (including curatorship)&#xD;
&#xD;
          -  History of any other clinically active malignancy in the last 5 years prior to&#xD;
             inclusion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Enora DOLIVET, MD</last_name>
    <phone>02 31 45 50 50</phone>
    <email>e.dolivet@baclesse.unicancer.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre François BACLESSE</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Enora DOLIVET, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ex vivo</keyword>
  <keyword>predictive tests</keyword>
  <keyword>tumor models</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</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/NCT03831230
org study id: 2018-A02152-53
nct id: NCT03831230
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.
observational model: Cohort
time perspective: Prospective
measure: Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests
time frame: Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery
description: Number and quality of tumor, blood and urine samples that can be used to perform predictive tests of the response to treatment
intervention type: Genetic
intervention name: collection of blood, urine, tumor and ascite samples
description: collection of blood, urine, tumor and ascite samples during ovarian surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Enora DOLIVET, MD
phone: 02 31 45 50 50
email: e.dolivet@baclesse.unicancer.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
sharing ipd: Undecided