xml: <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/NCT05977829</url>
    </required_header>
    <id_info>
      <org_study_id>691</org_study_id>
      <nct_id>NCT05977829</nct_id>
    </id_info>
    <brief_title>Endometrial Malignancy in Breast Cancer Patients With or Without AUB</brief_title>
    <acronym>TamAUB</acronym>
    <official_title>Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of&#xD;
        uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine&#xD;
        bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or&#xD;
        without AUB.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according&#xD;
        to recent studies. Many large (&gt;2 cm) and molecularly changed uterine polyps are usually seen&#xD;
        in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises&#xD;
        the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies&#xD;
        suggest that women who use TAM may also have an increase in the prevalence of uterine&#xD;
        sarcomas. In addition, the duration of TAM administration appears to increase the risk of&#xD;
        endometrial cancer and uterine sarcoma.&#xD;
  &#xD;
        This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and&#xD;
        histopathologic findings in postmenopausal women treated for breast cancer with or without&#xD;
        AUB in order to increase the robustness of a still ambiguous literature on the subject. It&#xD;
        will estimate the risk of endometrial cancer in women with AUB according to various&#xD;
        covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">July 30, 2022</completion_date>
    <primary_completion_date type="Actual">June 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Endometrial cancer rate</measure>
      <time_frame>1 month after admission</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Endometrial hyperplasia rate</measure>
      <time_frame>1 month after admission</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">283</enrollment>
    <condition>Endometrial Neoplasms</condition>
    <arm_group>
      <arm_group_label>Breast cancer patients with abnormal uterine bleeding</arm_group_label>
      <description>Transvaginal ultrasonography&#xD;
  Outpatient Hysteroscopy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Breast cancer patients without abnormal uterine bleeding</arm_group_label>
      <description>Transvaginal ultrasonography&#xD;
  Outpatient Hysteroscopy</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>Transvaginal ultrasound to carry out uterine surveillance</description>
      <arm_group_label>Breast cancer patients with abnormal uterine bleeding</arm_group_label>
      <arm_group_label>Breast cancer patients without abnormal uterine bleeding</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Hysteroscopy</intervention_name>
      <description>Outpatient hysteroscopy to carry out uterine surveillance</description>
      <arm_group_label>Breast cancer patients with abnormal uterine bleeding</arm_group_label>
      <arm_group_label>Breast cancer patients without abnormal uterine bleeding</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Endometrial biopsy for histopathological analysis.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Women undergoing gynecological examinations for endometrial surveillance related to&#xD;
          selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for&#xD;
          breast cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  In case of AUB: ultrasonographic endometrial thickness &gt;5 mm at transvaginal&#xD;
               ultrasound&#xD;
  &#xD;
            -  In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial&#xD;
               abnormalities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  severe comorbidities (cardiovascular, metabolic, endocrine, and immunological&#xD;
               disorders)&#xD;
  &#xD;
            -  receiving any other form of pharmacologic therapy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>43 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gaetano Riemma, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Pasquale De Franciscis, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Bologna Alma Mater Studiorum</name>
        <address>
          <city>Bologna</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Cagliari</name>
        <address>
          <city>Cagliari</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Genoa</name>
        <address>
          <city>Genova</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Naples Federico II</name>
        <address>
          <city>Napoli</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
      <investigator_full_name>Gaetano Riemma</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977829
  org study id: 691
  nct id: NCT05977829
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of
        uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine
        bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or
        without AUB.
  20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according
        to recent studies. Many large (>2 cm) and molecularly changed uterine polyps are usually seen
        in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises
        the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies
        suggest that women who use TAM may also have an increase in the prevalence of uterine
        sarcomas. In addition, the duration of TAM administration appears to increase the risk of
        endometrial cancer and uterine sarcoma.
  
        This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and
        histopathologic findings in postmenopausal women treated for breast cancer with or without
        AUB in order to increase the robustness of a still ambiguous literature on the subject. It
        will estimate the risk of endometrial cancer in women with AUB according to various
        covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.
  observational model: Cohort
  time perspective: Retrospective
  measure: Endometrial cancer rate
  time frame: 1 month after admission
  measure: Endometrial hyperplasia rate
  time frame: 1 month after admission
  arm group label: Breast cancer patients with abnormal uterine bleeding
  description: Transvaginal ultrasonography
  Outpatient Hysteroscopy
  arm group label: Breast cancer patients without abnormal uterine bleeding
  description: Transvaginal ultrasonography
  Outpatient Hysteroscopy
  intervention type: Diagnostic Test
  intervention name: Ultrasound
  description: Transvaginal ultrasound to carry out uterine surveillance
  arm group label: Breast cancer patients with abnormal uterine bleeding
  arm group label: Breast cancer patients without abnormal uterine bleeding
  intervention type: Diagnostic Test
  intervention name: Hysteroscopy
  description: Outpatient hysteroscopy to carry out uterine surveillance
  arm group label: Breast cancer patients with abnormal uterine bleeding
  arm group label: Breast cancer patients without abnormal uterine bleeding
  Endometrial biopsy for histopathological analysis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 43 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Gaetano Riemma, MD
  role: Principal Investigator
  affiliation: University of Campania "Luigi Vanvitelli"
  last name: Pasquale De Franciscis, MD PhD
  role: Study Chair
  affiliation: University of Campania "Luigi Vanvitelli"
  facility: 
  facility: 
  facility: 
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Campania "Luigi Vanvitelli"
  investigator full name: Gaetano Riemma
  investigator title: Principal Investigator
  mesh term: Endometrial Neoplasms