<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/NCT03010124</url>
  </required_header>
  <id_info>
    <org_study_id>2015-A01183-46</org_study_id>
    <secondary_id>2015/2290</secondary_id>
    <nct_id>NCT03010124</nct_id>
  </id_info>
  <brief_title>Prognostic and Predictive Biomarkers in Ovarian Cancers</brief_title>
  <acronym>OvBIOMark</acronym>
  <official_title>Prognostic and Predictive Biomarkers in Ovarian Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators therefore propose to conduct a biological study of prospectively collected&#xD;
      patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical&#xD;
      smear) throughout the disease course where markers (at diagnosis and their change with&#xD;
      treatment) will be correlated to outcome in order to investigate how genetic diversity in OC&#xD;
      prior to treatment and adaptation following treatment contribute to chemotherapy resistance.&#xD;
      In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex&#xD;
      vivo DNA repair functional assays and isolated in primary culture (and established as&#xD;
      xenografts) for target validation experiments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 26, 2016</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Progression Free Survival</measure>
    <time_frame>Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion</time_frame>
    <description>up to 12 months</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with ovarian cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <arm_group_label>Patients with ovarian cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. New patient with a diagnosis of OC, or&#xD;
&#xD;
          2. Previously treated patient with frozen or formalin fixed paraffin embedded primary&#xD;
             tumour sample available that can be retrieved by the center presenting with&#xD;
             progressive disease, and consenting to CT guided biopsy of relapsed disease, or&#xD;
&#xD;
          3. Previously treated patient with frozen or formalin fixed paraffin embedded primary&#xD;
             tumour sample available that can be retrieved by the center scheduled for surgery for&#xD;
             relapsed disease.&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
          5. Age ≥ 18&#xD;
&#xD;
          6. Patient affiliated to a social security regimen or beneficiary of the same&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral&#xD;
             treatment;&#xD;
&#xD;
          2. Coagulation abnormalities that contra-indicates the biopsy&#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_contact>
    <last_name>Alexandra LEARY, MD</last_name>
    <phone>0142114389</phone>
    <phone_ext>+33</phone_ext>
    <email>alexandra.leary@gustaveroussy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ariane DUNANT</last_name>
    <phone>0142114211</phone>
    <phone_ext>+33</phone_ext>
    <email>ariane.dunant@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val De Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra LEARY, MD</last_name>
      <phone>0142114389</phone>
      <phone_ext>+33</phone_ext>
      <email>alexandra.leary@gustaveroussy.fr</email>
    </contact>
    <contact_backup>
      <last_name>Ariane DUNANT</last_name>
      <phone>0142114211</phone>
      <phone_ext>+33</phone_ext>
      <email>ariane.dunant@gustaveroussy.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</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>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT03010124
org study id: 2015-A01183-46
secondary id: 2015/2290
nct id: NCT03010124
lead sponsor: 
has dmc: No
The investigators therefore propose to conduct a biological study of prospectively collected
      patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical
      smear) throughout the disease course where markers (at diagnosis and their change with
      treatment) will be correlated to outcome in order to investigate how genetic diversity in OC
      prior to treatment and adaptation following treatment contribute to chemotherapy resistance.
      In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex
      vivo DNA repair functional assays and isolated in primary culture (and established as
      xenografts) for target validation experiments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Progression Free Survival
time frame: Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion
description: up to 12 months
arm group label: Patients with ovarian cancer
arm group type: Other
intervention type: Procedure
intervention name: Blood sample
arm group label: Patients with ovarian cancer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandra LEARY, MD
phone: 0142114389
phone ext: +33
email: alexandra.leary@gustaveroussy.fr
last name: Ariane DUNANT
phone: 0142114211
phone ext: +33
email: ariane.dunant@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No