<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/NCT03275298</url>
  </required_header>
  <id_info>
    <org_study_id>ESMEOVR</org_study_id>
    <nct_id>NCT03275298</nct_id>
  </id_info>
  <brief_title>Evolution of the Therapeutic Care in Ovarian Cancer From 2011</brief_title>
  <acronym>ESME-OVR</acronym>
  <official_title>Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UNICANCER</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The ESME OVR Data Platform is a multi-center real life database using a retrospective data&#xD;
      collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This&#xD;
      database compiles data from Patient's Electronic medical records (EMR), inpatient&#xD;
      Hospitalisation records and Pharmacy records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This database compiles data from Patient's Electronic medical records (EMR), inpatient&#xD;
      Hospitalisation records and Pharmacy records.&#xD;
&#xD;
      Patient Database: Patient-related data integrates data from non-structured sources&#xD;
      (electronic medical records), such as patient medical records and reports of multidiscipline&#xD;
      team meetings. It can provide information on patient demographics, primitive tumour,&#xD;
      relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal&#xD;
      reasons when applicable, and clinical events.&#xD;
&#xD;
      Treatment Database: Pharmacy records-related data is a structured database including all data&#xD;
      pertaining to medications prescribed and dispensed by pharmacies within each FCCC,&#xD;
      specifically chemotherapy and co-prescriptions. It does not contain information on products&#xD;
      that are prescribed or delivered outside of the center. From each center's pharmacy database,&#xD;
      information on systemic treatment patterns (dates, pharmaceutical forms, treatment protocols,&#xD;
      etc.) can be obtained.&#xD;
&#xD;
      Hospitalisation Database: Hospitalisation-related data is a structured and systematic&#xD;
      database that contains all medical data reported related to any hospitalisation in the FCCC,&#xD;
      and is used to bill the French National Health Insurance Fund (Assurance Maladie). It&#xD;
      provides information on patient entry and discharge dates as well as diagnostic and&#xD;
      therapeutic procedures performed, including radiotherapy and surgery.&#xD;
&#xD;
      Data imported into the final database are controlled, recoded, and harmonized before import&#xD;
      according to a data management plan. All coding procedures are predefined by the data&#xD;
      manager. There is no transmission of individual data; all data are centralized within each&#xD;
      center using a shared anonymous format. All data are exclusively obtained retrospectively; no&#xD;
      attempts are made to recover non available data from the patient's medical record by&#xD;
      contacting healthcare providers or patients.&#xD;
&#xD;
      ESME OVR Data Platform aims to be a clinical and therapeutic database centralising existing&#xD;
      and available data from different sources used in the FCCCs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    enrolment temporariliy stopped for budget considerations&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers</measure>
    <time_frame>baseline</time_frame>
    <description>Patient characteristics, tumor characteristics and treatment patterns</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe the impact of therapeutic strategies on survival criteria</measure>
    <time_frame>From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Describe the impact of therapeutic strategies on survival criteria</measure>
    <time_frame>From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2022.</time_frame>
    <description>Progression free survival</description>
  </other_outcome>
  <enrollment type="Actual">13331</enrollment>
  <condition>Ovarian Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive females treated for an ovarian cancer in a French Comprehensive Cancer&#xD;
        Center over the selection period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  18 years old female&#xD;
&#xD;
          -  Female receiving surgery, chemotherapy, targeted therapy, immunotherapy, radiation&#xD;
             therapy, diagnostic procedure, other specific therapeutic procedure) in a French&#xD;
             Comprehensive Cancer Center.&#xD;
&#xD;
        Exclusion criteria : None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest - Paul Papin</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges-François Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli-Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut régional du Cancer Montpellier / Val d'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de cancérologie de l'Ouest - René Gauducheau</name>
      <address>
        <city>Nantes</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <zip>51056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugène Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie - Hôpital René Huguenin</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Paul Strauss</name>
      <address>
        <city>Strasbourg</city>
        <zip>67065</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Romeo, C, P Meeus, M Rodrigues, E Leblanc, A Floquet, P Pautier, F Marchal, et al. &quot; EP967 Natural history of patients with BRCA-mutated high grade epithelial ovarian cancer (HGEOC) before the era of PARP inhibitors maintenance in 1st line treatment &quot;. In ePoster, A513.3-A513. BMJ Publishing Group Ltd, 2019. https://doi.org/10.1136/ijgc-2019-ESGO.1013.</citation>
  </results_reference>
  <results_reference>
    <citation>De Nonneville A, Zemmour C, Frank S, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Sauterey B, Leblanc E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Gladieff L, Simon G, Courtinard C, Sabatier R. Clinicopathological characterization of a real-world multicenter cohort of endometrioid ovarian carcinoma: Analysis of the French national ESME-Unicancer database. Gynecol Oncol. 2021 Oct;163(1):64-71. doi: 10.1016/j.ygyno.2021.07.019. Epub 2021 Jul 19.</citation>
    <PMID>34294414</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodrigues M, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Provensal Gross M, Leblac E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Courtinard C, Gladieff L. Real-world clinical outcomes of patients with de novo advanced high-grade epithelial ovarian cancer eligible to niraparib maintenance in France. ESMO Congress, September 16-21, 2021 [ePoster 746P] DOI:https://doi.org/10.1016/j.annonc.2021.08.1188</citation>
  </results_reference>
  <results_reference>
    <citation>Thomas QD, Boussere A, Classe JM, Pomel C, Costaz H, Rodrigues M, Ray-Coquard I, Gladieff L, Rouzier R, Rouge TM, Gouy S, Barranger E, Sabatier R, Floquet A, Marchal F, Guillemet C, Polivka V, Martin AL, Colombo PE, Fiteni F. Optimal timing of interval debulking surgery for advanced epithelial ovarian cancer: A retrospective study from the ESME national cohort. Gynecol Oncol. 2022 Oct;167(1):11-21. doi: 10.1016/j.ygyno.2022.08.005. Epub 2022 Aug 13.</citation>
    <PMID>35970603</PMID>
  </results_reference>
  <results_reference>
    <citation>Bini M, Quesada S, Meeus P, Rodrigues M, Leblanc E, Floquet A, Pautier P, Marchal F, Provansal M, Campion L, Causeret S, Gourgou S, Ray-Coquard I, Classe JM, Pomel C, De La Motte Rouge T, Barranger E, Savoye AM, Guillemet C, Gladieff L, Demarchi M, Rouzier R, Courtinard C, Romeo C, Joly F. Real-World Data on Newly Diagnosed BRCA-Mutated High-Grade Epithelial Ovarian Cancers: The French National Multicenter ESME Database. Cancers (Basel). 2022 Aug 21;14(16):4040. doi: 10.3390/cancers14164040.</citation>
    <PMID>36011033</PMID>
  </results_reference>
  <results_reference>
    <citation>Brouillard-Saby F, Saint-Martin C, Ray-Coquard I, Gladieff L, Pomel C, Colombo PE, Classe JM, Chevrier M, Joly F, De la Motte Rouge T, Floquet A, Sabatier R, Barranger E, Costaz H, Leblanc E, Marchal F, Pautier P, Bosquet L, Rodrigues M. Efficacy of chemotherapy according to BRCA status in patients with high-grade serous ovarian carcinoma at first platinum-sensitive relapse. Int J Gynecol Cancer. 2023 Apr 3;33(4):577-584. doi: 10.1136/ijgc-2022-003993.</citation>
    <PMID>36631150</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>observational study</keyword>
  <keyword>survival</keyword>
  <keyword>real world data</keyword>
  <keyword>real life setting</keyword>
  <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/NCT03275298
org study id: ESMEOVR
nct id: NCT03275298
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The ESME OVR Data Platform is a multi-center real life database using a retrospective data
      collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This
      database compiles data from Patient's Electronic medical records (EMR), inpatient
      Hospitalisation records and Pharmacy records.
This database compiles data from Patient's Electronic medical records (EMR), inpatient
      Hospitalisation records and Pharmacy records.

      Patient Database: Patient-related data integrates data from non-structured sources
      (electronic medical records), such as patient medical records and reports of multidiscipline
      team meetings. It can provide information on patient demographics, primitive tumour,
      relapses, pathology reports, metastatic disease, therapeutic care/settings and withdrawal
      reasons when applicable, and clinical events.

      Treatment Database: Pharmacy records-related data is a structured database including all data
      pertaining to medications prescribed and dispensed by pharmacies within each FCCC,
      specifically chemotherapy and co-prescriptions. It does not contain information on products
      that are prescribed or delivered outside of the center. From each center's pharmacy database,
      information on systemic treatment patterns (dates, pharmaceutical forms, treatment protocols,
      etc.) can be obtained.

      Hospitalisation Database: Hospitalisation-related data is a structured and systematic
      database that contains all medical data reported related to any hospitalisation in the FCCC,
      and is used to bill the French National Health Insurance Fund (Assurance Maladie). It
      provides information on patient entry and discharge dates as well as diagnostic and
      therapeutic procedures performed, including radiotherapy and surgery.

      Data imported into the final database are controlled, recoded, and harmonized before import
      according to a data management plan. All coding procedures are predefined by the data
      manager. There is no transmission of individual data; all data are centralized within each
      center using a shared anonymous format. All data are exclusively obtained retrospectively; no
      attempts are made to recover non available data from the patient's medical record by
      contacting healthcare providers or patients.

      ESME OVR Data Platform aims to be a clinical and therapeutic database centralising existing
      and available data from different sources used in the FCCCs.
observational model: Cohort
time perspective: Retrospective
measure: Describe the evolution of therapeutic care in ovarian cancer across the French comprehensive cancer centers
time frame: baseline
description: Patient characteristics, tumor characteristics and treatment patterns
measure: Describe the impact of therapeutic strategies on survival criteria
time frame: From date of diagnosis or first treatment until the date of date of death from any cause. Follow up until 2022.
description: Overall survival
measure: Describe the impact of therapeutic strategies on survival criteria
time frame: From date of diagnosis or first treatment until the date of first documented progression or date of death from any cause. Follow up until 2022.
description: Progression free survival
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Romeo, C, P Meeus, M Rodrigues, E Leblanc, A Floquet, P Pautier, F Marchal, et al. " EP967 Natural history of patients with BRCA-mutated high grade epithelial ovarian cancer (HGEOC) before the era of PARP inhibitors maintenance in 1st line treatment ". In ePoster, A513.3-A513. BMJ Publishing Group Ltd, 2019. https://doi.org/10.1136/ijgc-2019-ESGO.1013.
citation: De Nonneville A, Zemmour C, Frank S, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Sauterey B, Leblanc E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Gladieff L, Simon G, Courtinard C, Sabatier R. Clinicopathological characterization of a real-world multicenter cohort of endometrioid ovarian carcinoma: Analysis of the French national ESME-Unicancer database. Gynecol Oncol. 2021 Oct;163(1):64-71. doi: 10.1016/j.ygyno.2021.07.019. Epub 2021 Jul 19.
PMID: 34294414
citation: Rodrigues M, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Provensal Gross M, Leblac E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Courtinard C, Gladieff L. Real-world clinical outcomes of patients with de novo advanced high-grade epithelial ovarian cancer eligible to niraparib maintenance in France. ESMO Congress, September 16-21, 2021 [ePoster 746P] DOI:https://doi.org/10.1016/j.annonc.2021.08.1188
citation: Thomas QD, Boussere A, Classe JM, Pomel C, Costaz H, Rodrigues M, Ray-Coquard I, Gladieff L, Rouzier R, Rouge TM, Gouy S, Barranger E, Sabatier R, Floquet A, Marchal F, Guillemet C, Polivka V, Martin AL, Colombo PE, Fiteni F. Optimal timing of interval debulking surgery for advanced epithelial ovarian cancer: A retrospective study from the ESME national cohort. Gynecol Oncol. 2022 Oct;167(1):11-21. doi: 10.1016/j.ygyno.2022.08.005. Epub 2022 Aug 13.
PMID: 35970603
citation: Bini M, Quesada S, Meeus P, Rodrigues M, Leblanc E, Floquet A, Pautier P, Marchal F, Provansal M, Campion L, Causeret S, Gourgou S, Ray-Coquard I, Classe JM, Pomel C, De La Motte Rouge T, Barranger E, Savoye AM, Guillemet C, Gladieff L, Demarchi M, Rouzier R, Courtinard C, Romeo C, Joly F. Real-World Data on Newly Diagnosed BRCA-Mutated High-Grade Epithelial Ovarian Cancers: The French National Multicenter ESME Database. Cancers (Basel). 2022 Aug 21;14(16):4040. doi: 10.3390/cancers14164040.
PMID: 36011033
citation: Brouillard-Saby F, Saint-Martin C, Ray-Coquard I, Gladieff L, Pomel C, Colombo PE, Classe JM, Chevrier M, Joly F, De la Motte Rouge T, Floquet A, Sabatier R, Barranger E, Costaz H, Leblanc E, Marchal F, Pautier P, Bosquet L, Rodrigues M. Efficacy of chemotherapy according to BRCA status in patients with high-grade serous ovarian carcinoma at first platinum-sensitive relapse. Int J Gynecol Cancer. 2023 Apr 3;33(4):577-584. doi: 10.1136/ijgc-2022-003993.
PMID: 36631150
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No