<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/NCT02984423</url>
  </required_header>
  <id_info>
    <org_study_id>D0817R00002</org_study_id>
    <nct_id>NCT02984423</nct_id>
  </id_info>
  <brief_title>FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study</brief_title>
  <acronym>FLABRA</acronym>
  <official_title>Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to answer very important questions regarding the prevalence of somatic and&#xD;
      germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer&#xD;
      patients from Latin America. These answers may be extremely helpful in the counseling for&#xD;
      genetic risk and treatment approach in these populations and will aid in making treatment&#xD;
      decisions in the future&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to&#xD;
      evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across&#xD;
      understudied ethnic groups in Latin America. Secondary objectives of the study are to&#xD;
      evaluate the prevalence of sBRCAm versus gBRCAm in newly diagnosed ovarian cancer patients&#xD;
      and to describe current ovarian cancer counselling and treatment approach patterns at front&#xD;
      line setting across Latin America.&#xD;
&#xD;
      In the Screening Visit, consecutive eligible patients who have been newly diagnosed with&#xD;
      ovarian cancer within the last 120 days will be invited to participate. After having provided&#xD;
      consent, patients will be asked to provide ethnicity and cancer family history information.&#xD;
      Patients will self-identify to one or more of the defined broad ethnic groups (Native&#xD;
      American, Afro-Caribbean, Caucasian) based on self-reported ancestry information. Archived&#xD;
      tumor blocks or twenty 10-µm sections from eligible patients will be requested from the local&#xD;
      pathology lab and used for BRCA mutations testing.&#xD;
&#xD;
      Patient medical records will be reviewed for data relevant to the ovarian cancer diagnosis,&#xD;
      including basic demographics, medical history, and treatment history.&#xD;
&#xD;
      During the Devolution Visit, results of the tumor BRCA test will be communicated to the&#xD;
      patient, and information about counselling approach and treatment plan will be recorded in&#xD;
      the medical chart. This Devolution Visit will be the last visit for this study for the cases&#xD;
      of non-mutated patients. For patients for whom a BRCA mutation have been identified in tumor,&#xD;
      additional test in blood looking for the specific point mutation found in tumor will be&#xD;
      performed to investigate if these patients harbor a germline BRCA mutation. For these&#xD;
      patients a further visit will be organised to communicate results to the patient and data&#xD;
      regarding germline test results will be recorded in the medical chart of the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2016</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population</measure>
    <time_frame>up to one year</time_frame>
    <description>FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across understudied ethnic groups in Latin America</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population</measure>
    <time_frame>up to one year</time_frame>
    <description>To estimate the prevalence of gBRCAm in newly diagnosed ovarian cancer patients who have a BRCA mutation identified in the tumor sample, in LATAM population, and by ethnic sub-groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Counselling approach in ovarian cancer across Latinamerican countries</measure>
    <time_frame>up to one year</time_frame>
    <description>To describe all professionals participating in this process, and time for the approach</description>
  </secondary_outcome>
  <enrollment type="Actual">471</enrollment>
  <condition>Ovarian Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Archived tumor blocks or twenty 10-µm sections from eligible patients will be requested from&#xD;
      the local pathology lab and used for BRCA mutations testing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed patients with (FIGO) stage III or IV ovarian epithelial, primary&#xD;
        peritoneal, or fallopian tube cancer made&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclussion criteria:&#xD;
&#xD;
          1. Be able and willing to sign the informed consent form&#xD;
&#xD;
          2. Be older than 18 years of age&#xD;
&#xD;
          3. Have histologically confirmed new diagnosis of Federation of Gynecology and Obstetrics&#xD;
             stage III or IV ovarian epithelial, primary peritoneal, or fallopian tube cancer made&#xD;
             by one or more of the following:&#xD;
&#xD;
               -  standard staging laparotomy including bilateral salpingo-oophorectomy,&#xD;
                  omentectomy, and lymph node sampling and debulking and or&#xD;
&#xD;
               -  surgical resection and radiographic evidence consistent with Stage 3 or 4 ovarian&#xD;
                  cancer&#xD;
&#xD;
               -  paracentesis or biopsy with radiographic evidence consistent with Stage III or IV&#xD;
                  ovarian cancer (normal appearing pancreas, liver, and gastrointestinal tract)&#xD;
&#xD;
          4. Have availability of paraffin-embedded archived tumor tissue block (preferred) or, if&#xD;
             a block is not possible, a minimum of twenty 10 microm sections&#xD;
&#xD;
          5. Have a diagnosis that is within 120 days of informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Have a diagnosis of any severe acute or chronic medical or psychiatric conditions that&#xD;
             may increase the risk associated with study participation or may interfere with the&#xD;
             interpretation of the study results and, in the judgement of the Investigator, would&#xD;
             make the patient inappropriate for enrollment in this study&#xD;
&#xD;
          2. Be a patient who, in the judgement of the Investigator, would be inappropriate for&#xD;
             enrollment in this study&#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>Buenos Aires</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1431FWO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caba</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Rioja</city>
        <zip>5300</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Resistencia</city>
        <zip>3500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rosario</city>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barretos</city>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belo Horizonte</city>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Curitiba</city>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fortaleza</city>
        <zip>60336-045</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fortaleza</city>
        <zip>60430-230</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jaú</city>
        <zip>17210-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20560-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salvador</city>
        <zip>41950-610</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>São Paulo</city>
        <zip>01317-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cali</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Medellín</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>México</city>
        <zip>1400</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ciudad de Panama</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>0051</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lima</city>
        <zip>LIMA 11</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Isidro</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Colombia</country>
    <country>Mexico</country>
    <country>Panama</country>
    <country>Peru</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D0817R00002&amp;amp;attachmentIdentifier=34f1602d-4fbf-424b-b632-55352d326864&amp;amp;fileName=20200708_FLABRA_CSR_summary.pdf&amp;amp;versionIdentifier=</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <keyword>BRCA mutations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</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/NCT02984423
org study id: D0817R00002
nct id: NCT02984423
lead sponsor: 
has dmc: No
This study aims to answer very important questions regarding the prevalence of somatic and
      germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer
      patients from Latin America. These answers may be extremely helpful in the counseling for
      genetic risk and treatment approach in these populations and will aid in making treatment
      decisions in the future
FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to
      evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across
      understudied ethnic groups in Latin America. Secondary objectives of the study are to
      evaluate the prevalence of sBRCAm versus gBRCAm in newly diagnosed ovarian cancer patients
      and to describe current ovarian cancer counselling and treatment approach patterns at front
      line setting across Latin America.

      In the Screening Visit, consecutive eligible patients who have been newly diagnosed with
      ovarian cancer within the last 120 days will be invited to participate. After having provided
      consent, patients will be asked to provide ethnicity and cancer family history information.
      Patients will self-identify to one or more of the defined broad ethnic groups (Native
      American, Afro-Caribbean, Caucasian) based on self-reported ancestry information. Archived
      tumor blocks or twenty 10-µm sections from eligible patients will be requested from the local
      pathology lab and used for BRCA mutations testing.

      Patient medical records will be reviewed for data relevant to the ovarian cancer diagnosis,
      including basic demographics, medical history, and treatment history.

      During the Devolution Visit, results of the tumor BRCA test will be communicated to the
      patient, and information about counselling approach and treatment plan will be recorded in
      the medical chart. This Devolution Visit will be the last visit for this study for the cases
      of non-mutated patients. For patients for whom a BRCA mutation have been identified in tumor,
      additional test in blood looking for the specific point mutation found in tumor will be
      performed to investigate if these patients harbor a germline BRCA mutation. For these
      patients a further visit will be organised to communicate results to the patient and data
      regarding germline test results will be recorded in the medical chart of the patient.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population
time frame: up to one year
description: FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across understudied ethnic groups in Latin America
measure: Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population
time frame: up to one year
description: To estimate the prevalence of gBRCAm in newly diagnosed ovarian cancer patients who have a BRCA mutation identified in the tumor sample, in LATAM population, and by ethnic sub-groups
measure: Counselling approach in ovarian cancer across Latinamerican countries
time frame: up to one year
description: To describe all professionals participating in this process, and time for the approach
Archived tumor blocks or twenty 10-µm sections from eligible patients will be requested from
      the local pathology lab and used for BRCA mutations testing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Brazil
country: Colombia
country: Mexico
country: Panama
country: Peru
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D0817R00002&amp;attachmentIdentifier=34f1602d-4fbf-424b-b632-55352d326864&amp;fileName=20200708_FLABRA_CSR_summary.pdf&amp;versionIdentifier=
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Ovarian Neoplasms