<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/NCT02222883</url>
  </required_header>
  <id_info>
    <org_study_id>AGO-TR 1</org_study_id>
    <nct_id>NCT02222883</nct_id>
  </id_info>
  <brief_title>Prevalence of BRCA in Patients With Ovarian Cancer</brief_title>
  <official_title>Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AGO Research GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AGO Research GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective registration and translational research study is to evaluate the&#xD;
      praevalence of BRCA regarding germline and somatic mutations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Explorative analysis will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</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>Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)</measure>
    <time_frame>once per sample</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Results of Immunohistochemistry in tumor samples</measure>
    <time_frame>once per sample</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)</measure>
    <time_frame>once per sample</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BRCAness tumor phenotype in ovarian cancer (yes/no).</measure>
    <time_frame>once per sample</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences of tumor samples from primary and relapsed disease</measure>
    <time_frame>once per sample for each stage of disease</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Survey for perspectives and satisfaction regarding testing and counseling</measure>
    <time_frame>once after BRCA result is available</time_frame>
    <description>3 questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies</measure>
    <time_frame>once</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014)</measure>
    <time_frame>once</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Evaluate predictive value of PARp-1 expression for HRD mutations</measure>
    <time_frame>once for all samples</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">530</enrollment>
  <condition>BRCA Status</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>patients with primary diagnosis</arm_group_label>
    <description>patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with platinum-sensitive recurrence</arm_group_label>
    <description>patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Testing of BRCA status regarding germline and somatic mutation</intervention_name>
    <arm_group_label>patients with platinum-sensitive recurrence</arm_group_label>
    <arm_group_label>patients with primary diagnosis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      EDTA Blood sample Tumorblock&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        500 consecutive patients (up to 250 patients with primary diagnosis and up to 250 patients&#xD;
        with platinum-sensitive recurrence of ovarian cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female ovarian cancer patients aged &gt;= 18 years.&#xD;
&#xD;
          -  Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with&#xD;
             platinum-sensitive recurrent ovarian cancer.&#xD;
&#xD;
          -  Multiple platinum based prior therapies are allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-epithelial ovarian malignancy.&#xD;
&#xD;
          -  Platinum-resistant or refractory disease.&#xD;
&#xD;
          -  Paraffin embedded tumor samples not available.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philipp Harter, PhD MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kliniken Essen-Mitte, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt/Main</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NCT Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Gynäkologische Onkologie</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen und Marburg</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LMU München, Klinik Großhadern</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Klinikum Offenbach</name>
      <address>
        <city>Offenbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Frauenklinik</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Horst Schmidt Kliniken</name>
      <address>
        <city>Wiesbaden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>June 11, 2021</last_update_submitted>
  <last_update_submitted_qc>June 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 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>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02222883
org study id: AGO-TR 1
nct id: NCT02222883
lead sponsor: 
has dmc: No
The aim of this prospective registration and translational research study is to evaluate the
      praevalence of BRCA regarding germline and somatic mutations.
Explorative analysis will be performed.
observational model: Cohort
time perspective: Prospective
measure: Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
time frame: once per sample
measure: Results of Immunohistochemistry in tumor samples
time frame: once per sample
measure: Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which)
time frame: once per sample
measure: BRCAness tumor phenotype in ovarian cancer (yes/no).
time frame: once per sample
measure: Differences of tumor samples from primary and relapsed disease
time frame: once per sample for each stage of disease
measure: Patient Survey for perspectives and satisfaction regarding testing and counseling
time frame: once after BRCA result is available
description: 3 questions
measure: Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies
time frame: once
measure: Validate the results from Pennington et al. (Pennington et al. Clin Cancer Res 2014)
time frame: once
measure: Evaluate predictive value of PARp-1 expression for HRD mutations
time frame: once for all samples
arm group label: patients with primary diagnosis
description: patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
arm group label: patients with platinum-sensitive recurrence
description: patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation
intervention type: Genetic
intervention name: Testing of BRCA status regarding germline and somatic mutation
arm group label: patients with platinum-sensitive recurrence
arm group label: patients with primary diagnosis
EDTA Blood sample Tumorblock
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philipp Harter, PhD MD
role: Study Chair
affiliation: Kliniken Essen-Mitte, Germany
facility: 
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country: Germany
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
sharing ipd: Undecided