<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/NCT04460768</url>
  </required_header>
  <id_info>
    <org_study_id>D0817R00028</org_study_id>
    <nct_id>NCT04460768</nct_id>
  </id_info>
  <brief_title>An INternational Frontline Ovarian Cancer Real World Management Study</brief_title>
  <acronym>INFORM</acronym>
  <official_title>A Multicountry, Multicenter, Retrospective Study Evaluating the Patient Characteristics, Disease Burden, Treatment Patterns, and Patient Journey of Advanced Epithelial Ovarian Cancer Patients: A Korean, Taiwanese, and Australian Secondary Database Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan&#xD;
      University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung&#xD;
      Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian&#xD;
      Ovarian Cancer Study [AOCS]) to leverage the already available data in the real-world setting&#xD;
      to review the current standard of care in advanced epithelial ovarian cancer cases. The&#xD;
      collected data will help provide the required information for assessing the unmet treatment&#xD;
      needs in this patient group. The data will also provide the needed information to support any&#xD;
      reimbursement activity needed for future novel therapies in this patient group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian cancer is the eighth most commonly diagnosed cancer (295,414 cases reported in 2018)&#xD;
      and the seventh leading cause of cancer-associated mortality (184,799 deaths reported in&#xD;
      2018) in women, worldwide. The increasing trends in the burden of ovarian cancer, coupled&#xD;
      with other challenges, such as lack of awareness of ovarian cancer risk factors, lack of&#xD;
      adequate screening tools, lack of access to diagnostics, and lack of trained clinicians,&#xD;
      contribute to delays in diagnosis, resulting in a high proportion of patients presenting with&#xD;
      advanced-stage ovarian cancer associated with high mortality. Over 75% of women with ovarian&#xD;
      cancer have been reported to be diagnosed at a late stage with high relapse rates, despite&#xD;
      first-line therapy. Studies in Asia have highlighted that about 65%-70% of women with ovarian&#xD;
      cancer are diagnosed at an advanced stage. Further, the five-year net survival rate of&#xD;
      advanced-stage ovarian cancer in Asia has been found to range from 14% to 41%.&#xD;
&#xD;
      Among the various ovarian cancer subtypes based on histology, epithelial ovarian cancer is&#xD;
      the most common type, reported in about 90% of cases. Specifically, type II epithelial&#xD;
      ovarian cancer (that includes serous carcinoma, mixed epithelial and stromal carcinoma,&#xD;
      undifferentiated carcinomas, and other epithelial carcinoma) accounts for about 66%-73%, 56%,&#xD;
      73%, and 73% in the US, Asia, Europe, and Oceania, respectively. The corresponding rates for&#xD;
      type I epithelial ovarian tumors (that include endometrioid, clear cell, mucinous, squamous,&#xD;
      and transitional cell carcinomas) have been noted to be 19%-21%, 32.5%, 20.5%, and 20%,&#xD;
      respectively. Regarding prognosis, the five-year net survival rate of type II epithelial&#xD;
      ovarian cancer that includes serous carcinoma has been found to be low when compared to other&#xD;
      subtypes across all regions. Of note, type II epithelial ovarian tumors have been reported to&#xD;
      be highly aggressive and usually present at an advanced stage, with poor survival rates. The&#xD;
      recurrence or relapse rates have also been noted to be high with epithelial serous ovarian&#xD;
      cancer. Furthermore, a strong association has been noted between family history of ovarian&#xD;
      cancer, a very strong risk factor, and the risk of developing aggressive serous carcinomas.&#xD;
      Genetic (both germline and somatic) mutations in BRCA1/2 have been noted in about 22% of&#xD;
      high-grade, serous, ovarian carcinomas, and the majority of hereditary cases (~44%). Also,&#xD;
      mutations in homologous recombination response genes have been noted in about 50% of&#xD;
      high-grade serous epithelial ovarian cancer cases.&#xD;
&#xD;
      Considering the high incidence, poor prognosis, and high morbidity and mortality from&#xD;
      advanced epithelial ovarian cancer, it is important to have well-organized databases on the&#xD;
      clinical characteristics, treatment patterns, and outcomes of these patients, to help&#xD;
      identify the unmet needs and gaps and further optimize the survival outcomes in these&#xD;
      patients. With exception of the UK, France, Germany, Italy, and Spain and the USA, there is&#xD;
      paucity of databases, registries, or published literature on patient level data pertaining to&#xD;
      treatment patterns, clinical characteristics, and outcomes of advanced ovarian cancer&#xD;
      patients. Therefore, the current study aims to analyze the existing secondary databases from&#xD;
      Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan&#xD;
      University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and&#xD;
      Australia (Australian Ovarian Cancer Study) to leverage the already available data in the&#xD;
      real-world setting to review the current standard of care in advanced epithelial ovarian&#xD;
      cancer cases. The collected data will help provide the required information for assessing the&#xD;
      unmet treatment needs in this patient group. The data will also provide the needed&#xD;
      information to support any reimbursement activity needed for future novel therapies in this&#xD;
      patient group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2020</start_date>
  <completion_date type="Actual">November 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018</time_frame>
    <description>In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platinum free interval</measure>
    <time_frame>Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018</time_frame>
    <description>The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018</time_frame>
    <description>The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of treatment</measure>
    <time_frame>Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018</time_frame>
    <description>The length of time from the start of anti-cancer treatment to end of anti-cancer treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first subsequent treatment</measure>
    <time_frame>Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018</time_frame>
    <description>The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018</time_frame>
    <description>Duration from the index date to the date of death (if available)</description>
  </secondary_outcome>
  <enrollment type="Actual">989</enrollment>
  <condition>Ovarian Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a non-interventional study that involves retrospective collection of data from&#xD;
        medical records of all patients who have been newly diagnosed with advanced-stage&#xD;
        epithelial ovarian cancer (high grade serous type epithelial ovarian cancer for Taiwan)&#xD;
        between the period Jan 2014-Dec 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects above the age of 18&#xD;
&#xD;
          -  Patients with a confirmed diagnosis of advanced-stage (FIGO III/IV) epithelial (Serous&#xD;
             [high or low grade], mucinous, endometrioid, clear cell, mixed, and others) ovarian&#xD;
             cancer between the period Jan 2014 and Dec 2018, provided at least 12 months data is&#xD;
             available (not mandatory to be ovarian cancer related) as a proxy of healthcare use&#xD;
             prior to the diagnosis of advanced-stage epithelial ovarian cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients being included in interventional clinical trials with PARPi for the treatment&#xD;
             of advanced-stage high-grade epithelial ovarian cancer treatment during the study&#xD;
             period&#xD;
&#xD;
          -  Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)&#xD;
&#xD;
          -  Other malignancies within the past five years, except adequately treated non-melanoma&#xD;
             skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in&#xD;
             situ; stage 1, grade 1 endometrial carcinoma; or other solid tumors including&#xD;
             lymphomas (without bone marrow involvement) curatively treated with no evidence of&#xD;
             disease for ≥5 years. Patients with a history of localized breast cancer may have been&#xD;
             eligible, provided they completed their adjuvant chemotherapy more than three years&#xD;
             prior to registration, and remained free of recurrent or metastatic disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>D0817R00028</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seoul</city>
        <zip>D0817R00028</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Taipei City</city>
        <zip>D0817R00028</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taipei City</city>
        <zip>D0817R00028</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D0817R00028&amp;amp;attachmentIdentifier=30b554f7-0338-4254-9a8f-a528fc2c1e33&amp;amp;fileName=D0817R00028_CSR_v1.0_clean_0823_r_Redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>D0817R00028_CSR_v1.0_clean_0823</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared.</ipd_description>
  </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/NCT04460768
org study id: D0817R00028
nct id: NCT04460768
lead sponsor: 
has dmc: Yes
is fda regulated device: No
The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan
      University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung
      Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian
      Ovarian Cancer Study [AOCS]) to leverage the already available data in the real-world setting
      to review the current standard of care in advanced epithelial ovarian cancer cases. The
      collected data will help provide the required information for assessing the unmet treatment
      needs in this patient group. The data will also provide the needed information to support any
      reimbursement activity needed for future novel therapies in this patient group
Ovarian cancer is the eighth most commonly diagnosed cancer (295,414 cases reported in 2018)
      and the seventh leading cause of cancer-associated mortality (184,799 deaths reported in
      2018) in women, worldwide. The increasing trends in the burden of ovarian cancer, coupled
      with other challenges, such as lack of awareness of ovarian cancer risk factors, lack of
      adequate screening tools, lack of access to diagnostics, and lack of trained clinicians,
      contribute to delays in diagnosis, resulting in a high proportion of patients presenting with
      advanced-stage ovarian cancer associated with high mortality. Over 75% of women with ovarian
      cancer have been reported to be diagnosed at a late stage with high relapse rates, despite
      first-line therapy. Studies in Asia have highlighted that about 65%-70% of women with ovarian
      cancer are diagnosed at an advanced stage. Further, the five-year net survival rate of
      advanced-stage ovarian cancer in Asia has been found to range from 14% to 41%.

      Among the various ovarian cancer subtypes based on histology, epithelial ovarian cancer is
      the most common type, reported in about 90% of cases. Specifically, type II epithelial
      ovarian cancer (that includes serous carcinoma, mixed epithelial and stromal carcinoma,
      undifferentiated carcinomas, and other epithelial carcinoma) accounts for about 66%-73%, 56%,
      73%, and 73% in the US, Asia, Europe, and Oceania, respectively. The corresponding rates for
      type I epithelial ovarian tumors (that include endometrioid, clear cell, mucinous, squamous,
      and transitional cell carcinomas) have been noted to be 19%-21%, 32.5%, 20.5%, and 20%,
      respectively. Regarding prognosis, the five-year net survival rate of type II epithelial
      ovarian cancer that includes serous carcinoma has been found to be low when compared to other
      subtypes across all regions. Of note, type II epithelial ovarian tumors have been reported to
      be highly aggressive and usually present at an advanced stage, with poor survival rates. The
      recurrence or relapse rates have also been noted to be high with epithelial serous ovarian
      cancer. Furthermore, a strong association has been noted between family history of ovarian
      cancer, a very strong risk factor, and the risk of developing aggressive serous carcinomas.
      Genetic (both germline and somatic) mutations in BRCA1/2 have been noted in about 22% of
      high-grade, serous, ovarian carcinomas, and the majority of hereditary cases (~44%). Also,
      mutations in homologous recombination response genes have been noted in about 50% of
      high-grade serous epithelial ovarian cancer cases.

      Considering the high incidence, poor prognosis, and high morbidity and mortality from
      advanced epithelial ovarian cancer, it is important to have well-organized databases on the
      clinical characteristics, treatment patterns, and outcomes of these patients, to help
      identify the unmet needs and gaps and further optimize the survival outcomes in these
      patients. With exception of the UK, France, Germany, Italy, and Spain and the USA, there is
      paucity of databases, registries, or published literature on patient level data pertaining to
      treatment patterns, clinical characteristics, and outcomes of advanced ovarian cancer
      patients. Therefore, the current study aims to analyze the existing secondary databases from
      Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan
      University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and
      Australia (Australian Ovarian Cancer Study) to leverage the already available data in the
      real-world setting to review the current standard of care in advanced epithelial ovarian
      cancer cases. The collected data will help provide the required information for assessing the
      unmet treatment needs in this patient group. The data will also provide the needed
      information to support any reimbursement activity needed for future novel therapies in this
      patient group.
observational model: Other
time perspective: Retrospective
measure: Progression-free survival
time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
description: In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.
measure: Platinum free interval
time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
description: The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period
measure: Time to progression
time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
description: The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.
measure: Duration of treatment
time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
description: The length of time from the start of anti-cancer treatment to end of anti-cancer treatment
measure: Time to first subsequent treatment
time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
description: The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression
measure: Overall survival
time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
description: Duration from the index date to the date of death (if available)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Korea, Republic of
country: Taiwan
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D0817R00028&amp;attachmentIdentifier=30b554f7-0338-4254-9a8f-a528fc2c1e33&amp;fileName=D0817R00028_CSR_v1.0_clean_0823_r_Redacted.pdf&amp;versionIdentifier=
description: D0817R00028_CSR_v1.0_clean_0823
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
sharing ipd: No
ipd description: No IPD will be shared.