<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/NCT03229122</url>
  </required_header>
  <id_info>
    <org_study_id>D0816R00013</org_study_id>
    <nct_id>NCT03229122</nct_id>
  </id_info>
  <brief_title>Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA</brief_title>
  <acronym>CHARLOTTE</acronym>
  <official_title>Japan CHARLOTTE: Characterizing the Cross-sectional Approach to Ovarian Cancer: Genetic Testing of BRCA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</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>
      The multi-centered, cross-sectional investigations shall be conducted in this study with the&#xD;
      objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with&#xD;
      epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-centered, cooperative and epidemiological observation study is so designed to&#xD;
      investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial&#xD;
      ovarian cancer, primary peritoneal cancer or fallopian tube cancer because such a ratio has&#xD;
      not yet been adequately clarified in Japan.&#xD;
&#xD;
      The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal&#xD;
      cancer or fallopian tube cancer shall be asked to participate in this study in order of&#xD;
      diagnosis. After obtaining their consents by the written informed consent following&#xD;
      appropriate explanation, investigations about the demographic information including the&#xD;
      cancer family history shall be performed. Subsequently, blood is collected for investigation&#xD;
      about gBRCAm. In addition, histological classification shall be conducted based on the&#xD;
      resected tumor tissues.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 26, 2016</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.</measure>
    <time_frame>Baseline</time_frame>
    <description>To be evaluated based on laboratory test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ownership ratio of gBRCAm when stratified according to the patients' demographics</measure>
    <time_frame>Baseline</time_frame>
    <description>To be evaluated by laboratory test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing</measure>
    <time_frame>Baseline</time_frame>
    <description>To be evaluated by questionnaire</description>
  </secondary_outcome>
  <enrollment type="Anticipated">446</enrollment>
  <condition>Ovarian Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      From all the eligible subjects who have already attached the signature to the written&#xD;
      informed consent, blood samples shall be collected. By using an assigned 10-mL EDTA-added&#xD;
      blood collecting glass tube, 7 mL of the blood is sampled. The blood samples are to be&#xD;
      recovered together with the specified test request form by Myriad and presence or absence of&#xD;
      gBRCAm shall be centrally determined by US Myriad Genetics. Treatments of the samples,&#xD;
      handling procedures and recovery methods are precisely described on the testing manual.&#xD;
&#xD;
      The physician responsible for institutional study has the responsibility to notify the gBRCAm&#xD;
      results to all the patients who underwent the tests. However, this responsibility needs not&#xD;
      to be observed if the patients themselves refuse such a notification about gBRCAm test&#xD;
      results. This responsibility shall be assumed by the physician responsible for institutional&#xD;
      study in each participating institute.&#xD;
&#xD;
      Incidentally, the genetic test results of the patients should&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or&#xD;
        fallopian tube cancer in Japan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For registration to this study, all of the following criteria should be satisfied:&#xD;
&#xD;
          1. The subject can attach the signature to the Informed Consent Form (ICF), besides&#xD;
             having his/her intention to put the signature.&#xD;
&#xD;
          2. Female Japanese at more than 20 years of age&#xD;
&#xD;
          3. The newly diagnosed patients whose epithelial ovarian cancer, primary peritoneal&#xD;
             cancer or fallopian tube cancer is histologically confirmed as FIGO from the subject&#xD;
             to obtain their utmost understandings. Limited to histopathological diagnosis based on&#xD;
             resected tumor specimens (except the cytodiagnosis by ascites paracentesis).&#xD;
&#xD;
          4. The histopathological specimens can be submitted to the central pathological judgment.&#xD;
&#xD;
          5. Within 60 days after diagnosis of epithelial ovarian cancer, primary peritoneal cancer&#xD;
             or fallopian tube cancer, the patient's written consent has been obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects who coincide any of the following exclusion criteria are designated to be&#xD;
             ineligible:&#xD;
&#xD;
               1. In case of the subjects who are diagnosed to have acute or chronic physical or&#xD;
                  severe mental diseases except cancer, and about whom the attending responsible&#xD;
                  physician makes judgement to say that participation of these subjects would&#xD;
                  possibly increase the risks or would probably disturb the interpretation of the&#xD;
                  study results.&#xD;
&#xD;
               2. In case of the subjects whose registration for the study is judged by the&#xD;
                  attending responsible physician as inappropriate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female Japanese at more than 20 years of age</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toru Sugiyama, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iwate Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daisuke Aoki, MD</last_name>
    <role>Study Director</role>
    <affiliation>Keio University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Takayuki Enomoto, MD. PhD.</last_name>
    <role>Study Director</role>
    <affiliation>School of Medicine, Niigata University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nobuhiro Takeshima, MD.</last_name>
    <role>Study Director</role>
    <affiliation>The Cancer Institute Hospital Of JFCR.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Junzo Kigawa, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The Matsue City Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yo Watanabe</last_name>
    <role>Study Director</role>
    <affiliation>The Tohoku Medical and Pharmaceutical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Masami Arai, MD. PhD.</last_name>
    <role>Study Director</role>
    <affiliation>The Cancer Institute Hospital Of JFCR.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aomori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Izumo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Maebashi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Matsuyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mie</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morioka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sendai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tochigi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toon</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tottori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=4549&amp;filename=Study_report_synopsis_D0816R00013_redacted.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>June 2, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>June 6, 2019</last_update_submitted>
  <last_update_submitted_qc>June 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer, gBRCAm</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/NCT03229122
org study id: D0816R00013
nct id: NCT03229122
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The multi-centered, cross-sectional investigations shall be conducted in this study with the
      objective of identifying the ownership ratio of gBRCAm on the newly diagnosed patients with
      epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
This multi-centered, cooperative and epidemiological observation study is so designed to
      investigate the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial
      ovarian cancer, primary peritoneal cancer or fallopian tube cancer because such a ratio has
      not yet been adequately clarified in Japan.

      The newly diagnosed eligible patients with epithelial ovarian cancer, primary peritoneal
      cancer or fallopian tube cancer shall be asked to participate in this study in order of
      diagnosis. After obtaining their consents by the written informed consent following
      appropriate explanation, investigations about the demographic information including the
      cancer family history shall be performed. Subsequently, blood is collected for investigation
      about gBRCAm. In addition, histological classification shall be conducted based on the
      resected tumor tissues.
observational model: Cohort
time perspective: Cross-Sectional
measure: Assessment of the ownership ratio of gBRCAm in the newly diagnosed patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer in Japan.
time frame: Baseline
description: To be evaluated based on laboratory test.
measure: Ownership ratio of gBRCAm when stratified according to the patients' demographics
time frame: Baseline
description: To be evaluated by laboratory test
measure: Evaluation of the satisfaction levels of the patients toward explanation about the BRCA genetic testing
time frame: Baseline
description: To be evaluated by questionnaire
From all the eligible subjects who have already attached the signature to the written
      informed consent, blood samples shall be collected. By using an assigned 10-mL EDTA-added
      blood collecting glass tube, 7 mL of the blood is sampled. The blood samples are to be
      recovered together with the specified test request form by Myriad and presence or absence of
      gBRCAm shall be centrally determined by US Myriad Genetics. Treatments of the samples,
      handling procedures and recovery methods are precisely described on the testing manual.

      The physician responsible for institutional study has the responsibility to notify the gBRCAm
      results to all the patients who underwent the tests. However, this responsibility needs not
      to be observed if the patients themselves refuse such a notification about gBRCAm test
      results. This responsibility shall be assumed by the physician responsible for institutional
      study in each participating institute.

      Incidentally, the genetic test results of the patients should
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female Japanese at more than 20 years of age
minimum age: 20 Years
maximum age: 130 Years
healthy volunteers: No
last name: Toru Sugiyama, MD
role: Principal Investigator
affiliation: Iwate Medical University
last name: Daisuke Aoki, MD
role: Study Director
affiliation: Keio University
last name: Takayuki Enomoto, MD. PhD.
role: Study Director
affiliation: School of Medicine, Niigata University
last name: Nobuhiro Takeshima, MD.
role: Study Director
affiliation: The Cancer Institute Hospital Of JFCR.
last name: Junzo Kigawa, MD, PhD
role: Study Director
affiliation: The Matsue City Hospital
last name: Yo Watanabe
role: Study Director
affiliation: The Tohoku Medical and Pharmaceutical University
last name: Masami Arai, MD. PhD.
role: Study Director
affiliation: The Cancer Institute Hospital Of JFCR.
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country: Japan
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4549&filename=Study_report_synopsis_D0816R00013_redacted.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: No