<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/NCT01711502</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-ORO-XXX-2012/1</org_study_id>
    <nct_id>NCT01711502</nct_id>
  </id_info>
  <brief_title>Epidemiology and Management of Metastatic Breast Cancer</brief_title>
  <official_title>Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort 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 is a multicenter, national, retrospective chart-review study that will be based on the&#xD;
      collection of data from electronical or paper-based medical records with available data on&#xD;
      female patients diagnosed with metastatic brest cancer . The main purpose of this study is to&#xD;
      provide accurate, evidence based description on the incidence of progression of metastatic&#xD;
      breast cancer and its clinical management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A&#xD;
      retrospective cohort study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage</measure>
    <time_frame>At 12 and 18 months after diagnosis</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The progression free survival (PFS) rates</measure>
    <time_frame>At 12 and 18 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The progression free survival (PFS) time</measure>
    <time_frame>At 18 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP)</measure>
    <time_frame>At 18 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The clinical and pathological characteristics of newly diagnosed MBC patients</measure>
    <time_frame>At 18 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients</measure>
    <time_frame>At 18 months after diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization associated with the disease in Romania</measure>
    <time_frame>At 18 months after diagnosis</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>Breast Cancer Nos Metastatic Recurrent</condition>
  <arm_group>
    <arm_group_label>Female patients diagosed with metastatic breast cancer</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients diagosed with metastatic breast cance, age &gt; 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged 18 years and over Diagnosis of breast cancer according to ICD-10&#xD;
             diagnostic criteria with confirmed metastasis&#xD;
&#xD;
          -  Confirmed diagnosis between 1st July 2010 - 30th June 2011&#xD;
&#xD;
          -  Female patient managed for her disease at the same setting where final diagnosis of&#xD;
             MBC was performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of concurrent or other primary malignancies (except curatively resected&#xD;
             non-melanoma skin cancer or in situ cervical cancer)&#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>Dediu Mrcea, SENIOR PHYSICIAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bucharest Institute of Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandru Eniu, SENIOR PHYSICIAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cluj Institute of Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Doina Coste Gherasim</name>
      <address>
        <city>Baia Mare</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daniel Ciurescu</name>
      <address>
        <city>Brasov</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Lucia Stanculeanu</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dragos Median</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mircea Dediu</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rodica Tudor</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandru Eniu</name>
      <address>
        <city>Cluj</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabriela Morar Bolba</name>
      <address>
        <city>Cluj</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bena Sandra</name>
      <address>
        <city>Craiova</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nelly Cherciu</name>
      <address>
        <city>Craiova</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diana Petroiu</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Simona Angelescu</name>
      <address>
        <city>Targoviste</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cristina Oprean</name>
      <address>
        <city>Timisoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stefan Curescu</name>
      <address>
        <city>Timisoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cristina Elen Pirau</name>
      <address>
        <city>Vaslui</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>January 29, 2014</last_update_submitted>
  <last_update_submitted_qc>January 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic breast cancer,</keyword>
  <keyword>epidemiology,</keyword>
  <keyword>retrospective cohort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT01711502
org study id: NIS-ORO-XXX-2012/1
nct id: NCT01711502
lead sponsor: 
has dmc: No
This is a multicenter, national, retrospective chart-review study that will be based on the
      collection of data from electronical or paper-based medical records with available data on
      female patients diagnosed with metastatic brest cancer . The main purpose of this study is to
      provide accurate, evidence based description on the incidence of progression of metastatic
      breast cancer and its clinical management.
Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A
      retrospective cohort study
observational model: Cohort
time perspective: Retrospective
measure: The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage
time frame: At 12 and 18 months after diagnosis
measure: The progression free survival (PFS) rates
time frame: At 12 and 18 months after diagnosis
measure: The progression free survival (PFS) time
time frame: At 18 months after diagnosis
measure: Time to progression (TTP)
time frame: At 18 months after diagnosis
measure: The clinical and pathological characteristics of newly diagnosed MBC patients
time frame: At 18 months after diagnosis
measure: The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients
time frame: At 18 months after diagnosis
measure: Health care utilization associated with the disease in Romania
time frame: At 18 months after diagnosis
arm group label: Female patients diagosed with metastatic breast cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dediu Mrcea, SENIOR PHYSICIAN
role: Principal Investigator
affiliation: Bucharest Institute of Oncology
last name: Alexandru Eniu, SENIOR PHYSICIAN
role: Principal Investigator
affiliation: Cluj Institute of Oncology
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country: Romania
responsible party type: Sponsor
mesh term: Breast Neoplasms