<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/NCT01705561</url>
  </required_header>
  <id_info>
    <org_study_id>GECOPERU 01-2012</org_study_id>
    <nct_id>NCT01705561</nct_id>
  </id_info>
  <brief_title>Evaluation of Attitudes About Fertility</brief_title>
  <official_title>Evaluation of Attitudes of Premenopausal Latin American Patients With Breast Cancer Towards the Risk of Loss Their Fertility by Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Estudios Clínicos Oncológicos Peruano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Organisation for Research and Treatment of Cancer - EORTC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo de Estudios Clínicos Oncológicos Peruano</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Assess the attitudes and feelings of premenopausal Latin American women towards the risk&#xD;
           of loss their fertility by adjuvant chemotherapy.&#xD;
&#xD;
        -  Correlate the attitudes with other variables including age at diagnosis, already having&#xD;
           children, number of children, level of instruction, marital status, frequency of&#xD;
           menstrual cycle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligibility criteria:&#xD;
&#xD;
        -  Latin American women with evidence of cancer diagnosis at premenopausal status&#xD;
&#xD;
        -  Over 18 years&#xD;
&#xD;
        -  Agree to sign the informed consent&#xD;
&#xD;
        -  No evidence of infertility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Breast Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        women with diagnosis of breast cancer in pre menopausal status&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with breast cancer diagnosis in premenopausal&#xD;
&#xD;
          -  over 18 years&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of infertility at diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HENRY L GOMEZ, DR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Grupo de Estudios Clínicos Oncológicos Peruano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Enfermedades Neoplasicas</name>
      <address>
        <city>Lima</city>
        <zip>34</zip>
        <country>Peru</country>
      </address>
    </facility>
    <contact>
      <last_name>HENRY GOEMZ, DR</last_name>
      <phone>+5112016500</phone>
      <phone_ext>2260</phone_ext>
      <email>hgomez@gecoperu.org</email>
    </contact>
    <investigator>
      <last_name>HENRY L GOMEZ, DR</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oncosalud</name>
      <address>
        <city>Lima</city>
        <zip>41</zip>
        <country>Peru</country>
      </address>
    </facility>
    <contact>
      <last_name>ALFREDO AGUILAR, MD</last_name>
      <phone>+5137900</phone>
      <email>aac@oncosalud.pe</email>
    </contact>
    <investigator>
      <last_name>Alfredo Aguilar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fertility</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>breast cancer</keyword>
  <keyword>latin american women</keyword>
  <keyword>pre menopausal</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/NCT01705561
org study id: GECOPERU 01-2012
nct id: NCT01705561
lead sponsor: 
collaborator: 
has dmc: Yes
-  Assess the attitudes and feelings of premenopausal Latin American women towards the risk
           of loss their fertility by adjuvant chemotherapy.

        -  Correlate the attitudes with other variables including age at diagnosis, already having
           children, number of children, level of instruction, marital status, frequency of
           menstrual cycle.
Eligibility criteria:

        -  Latin American women with evidence of cancer diagnosis at premenopausal status

        -  Over 18 years

        -  Agree to sign the informed consent

        -  No evidence of infertility.
observational model: Case-Only
time perspective: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: HENRY L GOMEZ, DR
role: Principal Investigator
affiliation: Grupo de Estudios Clínicos Oncológicos Peruano
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: Peru
responsible party type: Sponsor
mesh term: Breast Neoplasms