<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/NCT02981901</url>
  </required_header>
  <id_info>
    <org_study_id>Ovaire01</org_study_id>
    <nct_id>NCT02981901</nct_id>
  </id_info>
  <brief_title>Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France</brief_title>
  <acronym>Ovaire01</acronym>
  <official_title>Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Leon Berard</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cancer Côte d'or registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Calvados registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Leon Berard</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      No structured organization for ovarian first line management emerges in France. Management&#xD;
      across France seems to depend on regional contexts.&#xD;
&#xD;
      Regions display no specific organization or delineate regional network for the ovarian cancer&#xD;
      management or report centralized management revolving around referent centers. These&#xD;
      different templates present a major problem in identifying differences, costs and benefit.&#xD;
&#xD;
      To deal with this issue the Investigators propose a health economic evaluation based on&#xD;
      cost-effectiveness analyses, completed with a budget impact analysis. This study will&#xD;
      investigate the cost-effective management of patients with initial ovarian cancer using&#xD;
      databases representative of different parts of French territories.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained</measure>
    <time_frame>2 years after diagnosis</time_frame>
    <description>To perform a cost-effectiveness analysis in order to evaluate the most efficient organization for ovarian cancer in 1st line ot treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.</measure>
    <time_frame>2 years after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Budget impact analysis</measure>
    <time_frame>2 years after diagnosis</time_frame>
    <description>Cost assessment performed retrospectively for each patient: hospital stays, visits and other health-related costs will be identified and measured based on the French national Health Insurance perspective.&#xD;
QALY (Quality-Adjusted Life Year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-free survival (RFS)</measure>
    <time_frame>RFS will be assessed 2 years after diagnosis</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">376</enrollment>
  <condition>Ovarian Epithelial Cancer</condition>
  <arm_group>
    <arm_group_label>Patient with ovarian epithelial cancer</arm_group_label>
    <description>Ovarian epithelial cancer diagnosed in 2012</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient with ovarian epithelial cancer</intervention_name>
    <arm_group_label>Patient with ovarian epithelial cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with ovarian epithelial cancer diagnosed in 2012&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ovarian epithelial cancer initially diagnosed in 2012&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  Residency in France (Rhône-Alpes region, District of Calvados and Cotes d'Or)&#xD;
&#xD;
          -  First-line ovarian epithelial cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Relapsed ovarian epithelial cancer&#xD;
&#xD;
          -  Non epithelial ovarian cancer&#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>Isabelle RAY-COQUARD, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Leon Berard</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Calvados registry</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Côte d'or registry</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oveval</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 22, 2018</last_update_submitted>
  <last_update_submitted_qc>August 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</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>Carcinoma, Ovarian Epithelial</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/NCT02981901
org study id: Ovaire01
nct id: NCT02981901
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
No structured organization for ovarian first line management emerges in France. Management
      across France seems to depend on regional contexts.

      Regions display no specific organization or delineate regional network for the ovarian cancer
      management or report centralized management revolving around referent centers. These
      different templates present a major problem in identifying differences, costs and benefit.

      To deal with this issue the Investigators propose a health economic evaluation based on
      cost-effectiveness analyses, completed with a budget impact analysis. This study will
      investigate the cost-effective management of patients with initial ovarian cancer using
      databases representative of different parts of French territories.
observational model: Cohort
time perspective: Retrospective
measure: Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained
time frame: 2 years after diagnosis
description: To perform a cost-effectiveness analysis in order to evaluate the most efficient organization for ovarian cancer in 1st line ot treatment
measure: Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.
time frame: 2 years after diagnosis
measure: Budget impact analysis
time frame: 2 years after diagnosis
description: Cost assessment performed retrospectively for each patient: hospital stays, visits and other health-related costs will be identified and measured based on the French national Health Insurance perspective.
QALY (Quality-Adjusted Life Year)
measure: Relapse-free survival (RFS)
time frame: RFS will be assessed 2 years after diagnosis
arm group label: Patient with ovarian epithelial cancer
description: Ovarian epithelial cancer diagnosed in 2012
intervention type: Other
intervention name: Patient with ovarian epithelial cancer
arm group label: Patient with ovarian epithelial cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle RAY-COQUARD, PU-PH
role: Principal Investigator
affiliation: Centre Leon Berard
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma, Ovarian Epithelial