<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/NCT03296826</url>
  </required_header>
  <id_info>
    <org_study_id>JGOG3024</org_study_id>
    <secondary_id>UMIN000028740</secondary_id>
    <nct_id>NCT03296826</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2</brief_title>
  <official_title>Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Okayama University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Japanese Gynecologic Oncology Group (JGOG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan</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>
      To determine the incidence and risk factors in the development of ovarian, fallopian tube,&#xD;
      and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2&#xD;
      variants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women&#xD;
           carrying BRCA1/2 variants.&#xD;
&#xD;
        2. To investigate risk factors concerning the development of ovarian, fallopian tube, and&#xD;
           peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic&#xD;
           polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants.&#xD;
&#xD;
        3. To estimate the detection rates of occult cancer based on histopathological evaluations,&#xD;
           using risk-reducing salpingo-oophorectomy (RRSO).&#xD;
&#xD;
        4. To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian&#xD;
           tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those&#xD;
           not undergoing RRSO.&#xD;
&#xD;
        5. To identify clinicopathological features in women carrying BRCA1/2 variants who had&#xD;
           undergone RRSO.&#xD;
&#xD;
        6. To identify the appropriate interval or degree of surveillance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 8, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2032</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of ovarian, fallopian tube, and peritoneal carcinoma</measure>
    <time_frame>up to 15 years</time_frame>
    <description>Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.</measure>
    <time_frame>up to 15 years</time_frame>
    <description>Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from any cause</measure>
    <time_frame>up to 15 years</time_frame>
    <description>Death from any cause is a duration from the date of enrollment to the date of death from any cause. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deaths from ovarian, fallopian tube, and peritoneal cancers.</measure>
    <time_frame>up to 15 years</time_frame>
    <description>Deaths from ovarian, fallopian tube, and peritoneal cancers is a duration from the date of enrollment to the date of death from these cancers. If the subjects have undergone RRSO, the term is defined from the date of enrollment to the date of RRSO undergone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.</measure>
    <time_frame>up to 15 years</time_frame>
    <description>The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.</measure>
    <time_frame>up to 15 years</time_frame>
    <description>Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal cancer, including in the post-RRSO period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from any cause, including post-RRSO period.</measure>
    <time_frame>up to 15 years</time_frame>
    <description>Death from any cause, including post-RRSO period is a duration from the date of enrollment to the date of death from any cause, including in the post-RRSO period.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>BRCA1 and/or BRCA2 Variant Carriers</condition>
  <condition>Ovarian Carcinoma</condition>
  <condition>Fallopian Tube Carcinoma</condition>
  <condition>Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>BRCA1/2 variant carriers</arm_group_label>
    <description>Japanese women who carry BRCA 1/2 variants.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples (all subjects) for Germ-line DNA sequencing, Biospy samples(when subjects have&#xD;
      RRSO within follow-up duration)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        BRCA1 and/or BRCA2 variant carriers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women carrying BRCA1/2 variants (those with either BRCA1 or BRCA2 variants, or those&#xD;
             carrying both variants) and women carrying a variant of uncertain significance (VUS).&#xD;
&#xD;
          2. Women who have received sufficient genetic counseling at any medical institution,&#xD;
             prior to enrollment to the study.&#xD;
&#xD;
          3. Women who provide consent should be 20 years of age or older.&#xD;
&#xD;
          4. Women who provide written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women without ovarian or fallopian tube cancer at the time of informed consent.&#xD;
&#xD;
          2. Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not&#xD;
             excluding those with a personal history of breast cancer development.&#xD;
&#xD;
          3. Other individuals considered inappropriate for involvement in this study by the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Akira Hirasawa, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Okayama University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Akira Hirasawa, M.D., Ph.D.</last_name>
    <phone>+81-86-235-7436</phone>
    <email>hir-aki45@umin.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Okayama University</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Akira Hirasawa, M.D., Ph.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>December 25, 2022</last_update_submitted>
  <last_update_submitted_qc>December 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</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</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/NCT03296826
org study id: JGOG3024
secondary id: UMIN000028740
nct id: NCT03296826
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine the incidence and risk factors in the development of ovarian, fallopian tube,
      and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2
      variants.
1. To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women
           carrying BRCA1/2 variants.

        2. To investigate risk factors concerning the development of ovarian, fallopian tube, and
           peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic
           polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants.

        3. To estimate the detection rates of occult cancer based on histopathological evaluations,
           using risk-reducing salpingo-oophorectomy (RRSO).

        4. To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian
           tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those
           not undergoing RRSO.

        5. To identify clinicopathological features in women carrying BRCA1/2 variants who had
           undergone RRSO.

        6. To identify the appropriate interval or degree of surveillance.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
time frame: up to 15 years
description: Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct
measure: Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
time frame: up to 15 years
description: Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
measure: Death from any cause
time frame: up to 15 years
description: Death from any cause is a duration from the date of enrollment to the date of death from any cause. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct.
measure: Deaths from ovarian, fallopian tube, and peritoneal cancers.
time frame: up to 15 years
description: Deaths from ovarian, fallopian tube, and peritoneal cancers is a duration from the date of enrollment to the date of death from these cancers. If the subjects have undergone RRSO, the term is defined from the date of enrollment to the date of RRSO undergone.
measure: Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.
time frame: up to 15 years
description: The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
measure: Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.
time frame: up to 15 years
description: Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal cancer, including in the post-RRSO period.
measure: Death from any cause, including post-RRSO period.
time frame: up to 15 years
description: Death from any cause, including post-RRSO period is a duration from the date of enrollment to the date of death from any cause, including in the post-RRSO period.
arm group label: BRCA1/2 variant carriers
description: Japanese women who carry BRCA 1/2 variants.
Blood samples (all subjects) for Germ-line DNA sequencing, Biospy samples(when subjects have
      RRSO within follow-up duration)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
last name: Akira Hirasawa, M.D., Ph.D.
role: Study Chair
affiliation: Okayama University
last name: Akira Hirasawa, M.D., Ph.D.
phone: +81-86-235-7436
email: hir-aki45@umin.org
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Sponsor
mesh term: Carcinoma