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/NCT06014580</url>
    </required_header>
    <id_info>
      <org_study_id>LACOG 0521</org_study_id>
      <nct_id>NCT06014580</nct_id>
    </id_info>
    <brief_title>Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil</brief_title>
    <acronym>MADONNA</acronym>
    <official_title>Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Latin American Cooperative Oncology Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>GlaxoSmithKline</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Latin American Cooperative Oncology Group</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is&#xD;
        necessary to understand the high frequency of advanced disease. A better understanding of the&#xD;
        current situation will generate essential data for the future development of national or&#xD;
        international cooperative programs that aim to improve outcomes in these patients and&#xD;
        generate additional knowledge for much-needed clinical trials in this population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a retrospective observational cohort study. In this study, we will include patients&#xD;
        diagnosed with endometrium cancer from January 2016 to December 2019 in participating sites&#xD;
        and collect data on demographics, clinicopathological characteristics, treatment patterns,&#xD;
        and outcomes. Data will be collected from medical records in selected centers that comprise&#xD;
        different regions of Brazil.&#xD;
  &#xD;
        The patient data sources will be the medical records of the patients. Patients will continue&#xD;
        to receive treatment and clinical evaluations for endometrial cancer according to what is&#xD;
        determined by their medical team, according to the usual standards of treatment and clinical&#xD;
        practice of each center. To minimize patient selection bias, physicians should invite all&#xD;
        consecutive eligible patients.&#xD;
  &#xD;
        This study also provides for the collection and archiving of tumor tissue material. The&#xD;
        samples will be tested to characterize the molecular subtype of endometrial cancer and will&#xD;
        be sequentially stored in a biorepository to enable future translational studies, according&#xD;
        to national regulations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer</measure>
      <time_frame>At the time of diagnosis.</time_frame>
      <description>This measure encompasses key epidemiological factors of the Brazilian population diagnosed with endometrial cancer, including age distribution, racial and ethnic demographics, geographic regions, and relevant comorbidities. These details will provide insights into the demographic makeup of the study population.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Molecular Profile Analysis of Endometrial Cancer Cases</measure>
      <time_frame>Throughout the study period, an average of 36 month.</time_frame>
      <description>This measure focuses on analyzing the molecular profile of endometrial cancer cases in the Brazilian population. It includes information about specific genetic mutations, biomarkers, and molecular subtypes that are relevant to endometrial cancer. Understanding the molecular landscape can contribute to insights into disease progression and potential targeted therapies.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment Patterns for Endometrial Cancer in Brazil</measure>
      <time_frame>From diagnosis to completion of treatment, between January 2016 and December 2019.</time_frame>
      <description>This measure examines the treatment patterns employed for endometrial cancer within the Brazilian population. It includes details about types of treatments received, such as surgery, chemotherapy, radiation therapy, and hormonal therapy. Additionally, it explores the utilization of targeted therapies or immunotherapies.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Endometrial Cancer Outcomes in the Brazilian Population</measure>
      <time_frame>From diagnosis to the end of the study follow-up period, an average of 36 months.</time_frame>
      <description>This measure assesses the outcomes of endometrial cancer cases in the Brazilian population. It includes survival rates, disease recurrence rates, response to treatment, and overall disease progression. By evaluating these outcomes, a comprehensive understanding of the disease's impact on the population can be achieved.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">282</enrollment>
    <condition>Endometrial Cancer</condition>
    <arm_group>
      <arm_group_label>Patients diagnosed with endometrial cancer</arm_group_label>
      <description>Patients diagnosed with endometrial cancer between January 2016 and December 2019 at participating sites will be included.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational study</intervention_name>
      <description>This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.</description>
      <arm_group_label>Patients diagnosed with endometrial cancer</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women diagnosed with endometrial cancer between January 2016 and December 2019 at&#xD;
          participating research sites.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women ≥18 years&#xD;
  &#xD;
            -  Histological diagnosis of endometrial carcinoma.&#xD;
  &#xD;
            -  Diagnosis of endometrial cancer between January 2016 and December 2019.&#xD;
  &#xD;
            -  FIGO (International Federation of Gynecology and Obstetrics, 2018) Stage I - IV.&#xD;
  &#xD;
            -  Site and investigator with access to a medical record chart from which data can be&#xD;
               abstracted.&#xD;
  &#xD;
            -  Presence of a sample of tumor tissue (primary tumor or metastasis) available for&#xD;
               biomarker testing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Noninvasive endometrial cancer.&#xD;
  &#xD;
            -  Patients with a history of concurrent or previously treated non-endometrial&#xD;
               malignancies except for appropriately treated 1) non -metastatic non-melanoma skin&#xD;
               cancer and/or 2) non-metastatic low-grade thyroid tumors and/or 3) in situ carcinomas,&#xD;
               including cervix, colon, and skin.&#xD;
  &#xD;
            -  Nonepithelial histology (leiomyosarcoma, adenosarcoma, endometrial stromal sarcoma,&#xD;
               undifferentiated sarcoma, or other mesenchymal tumors.&#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>Andreia Cristina de Melo</last_name>
      <role>Principal Investigator</role>
      <affiliation>Latin American Cooperative Oncology Group</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Diana Rostirolla</last_name>
      <phone>+55 51 3384 5334</phone>
      <email>diana.rostirolla@lacogcancerresearch.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laura Vöelcker</last_name>
      <phone>+55 51 3384 5334</phone>
      <email>laura.voelcker@lacogcancerresearch.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>Endometrial Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06014580
  org study id: LACOG 0521
  nct id: NCT06014580
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An evaluation of the molecular and epidemiological aspects of endometrial cancer in Brazil is
        necessary to understand the high frequency of advanced disease. A better understanding of the
        current situation will generate essential data for the future development of national or
        international cooperative programs that aim to improve outcomes in these patients and
        generate additional knowledge for much-needed clinical trials in this population.
  This is a retrospective observational cohort study. In this study, we will include patients
        diagnosed with endometrium cancer from January 2016 to December 2019 in participating sites
        and collect data on demographics, clinicopathological characteristics, treatment patterns,
        and outcomes. Data will be collected from medical records in selected centers that comprise
        different regions of Brazil.
  
        The patient data sources will be the medical records of the patients. Patients will continue
        to receive treatment and clinical evaluations for endometrial cancer according to what is
        determined by their medical team, according to the usual standards of treatment and clinical
        practice of each center. To minimize patient selection bias, physicians should invite all
        consecutive eligible patients.
  
        This study also provides for the collection and archiving of tumor tissue material. The
        samples will be tested to characterize the molecular subtype of endometrial cancer and will
        be sequentially stored in a biorepository to enable future translational studies, according
        to national regulations.
  observational model: Cohort
  time perspective: Retrospective
  measure: Epidemiological Characteristics of the Brazilian Population with Endometrial Cancer
  time frame: At the time of diagnosis.
  description: This measure encompasses key epidemiological factors of the Brazilian population diagnosed with endometrial cancer, including age distribution, racial and ethnic demographics, geographic regions, and relevant comorbidities. These details will provide insights into the demographic makeup of the study population.
  measure: Molecular Profile Analysis of Endometrial Cancer Cases
  time frame: Throughout the study period, an average of 36 month.
  description: This measure focuses on analyzing the molecular profile of endometrial cancer cases in the Brazilian population. It includes information about specific genetic mutations, biomarkers, and molecular subtypes that are relevant to endometrial cancer. Understanding the molecular landscape can contribute to insights into disease progression and potential targeted therapies.
  measure: Treatment Patterns for Endometrial Cancer in Brazil
  time frame: From diagnosis to completion of treatment, between January 2016 and December 2019.
  description: This measure examines the treatment patterns employed for endometrial cancer within the Brazilian population. It includes details about types of treatments received, such as surgery, chemotherapy, radiation therapy, and hormonal therapy. Additionally, it explores the utilization of targeted therapies or immunotherapies.
  measure: Endometrial Cancer Outcomes in the Brazilian Population
  time frame: From diagnosis to the end of the study follow-up period, an average of 36 months.
  description: This measure assesses the outcomes of endometrial cancer cases in the Brazilian population. It includes survival rates, disease recurrence rates, response to treatment, and overall disease progression. By evaluating these outcomes, a comprehensive understanding of the disease's impact on the population can be achieved.
  arm group label: Patients diagnosed with endometrial cancer
  description: Patients diagnosed with endometrial cancer between January 2016 and December 2019 at participating sites will be included.
  intervention type: Other
  intervention name: Observational study
  description: This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
  arm group label: Patients diagnosed with endometrial cancer
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Andreia Cristina de Melo
  role: Principal Investigator
  affiliation: Latin American Cooperative Oncology Group
  last name: Diana Rostirolla
  phone: +55 51 3384 5334
  email: diana.rostirolla@lacogcancerresearch.org
  last name: Laura Vöelcker
  phone: +55 51 3384 5334
  email: laura.voelcker@lacogcancerresearch.org
  responsible party type: Sponsor
  mesh term: Endometrial Neoplasms
  sharing ipd: Undecided