<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/NCT04406779</url>
  </required_header>
  <id_info>
    <org_study_id>UsakU-Cevdet1</org_study_id>
    <nct_id>NCT04406779</nct_id>
  </id_info>
  <brief_title>The Frequency of Thyroid Diseases in Women With Breast Cancer</brief_title>
  <official_title>The Frequency of Thyroid Diseases in Women With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uşak University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uşak University</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>
      Breast cancer and thyroid disorders are important health challenges commonly encountered in&#xD;
      women. The relationship between both conditions still remains unknown. In this study, the&#xD;
      frequency of thyroid diseases was investigated in breast cancer patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>to investigate the frequency of thyroid diseases in breast cancer patients.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Thyroid Diseases</condition>
  <arm_group>
    <arm_group_label>Patients with breast cancer</arm_group_label>
    <description>Patients with breast cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy patients without breast cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies</intervention_name>
    <description>thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Patients with breast cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women, aged between 18-65 years who were diagnosed with breast cancer, but not underwent&#xD;
        surgery, radiotherapy or chemothreapy were included into the study as patients groups. Age&#xD;
        matched healthy controls were enrolled as controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women, the age between 18-65 years who were diagnosed with breast cancer, but not&#xD;
             underwent surgery, radiotherapy or chemothreapy were included into the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with pregnancy, known liver and renal failure, the history of any malignancy&#xD;
             other than breast cancer, undergoing a surgical operation due to breast cancer, also&#xD;
             those receiving chemotherapy/radiotherapy for the same reason or undergoing partial or&#xD;
             complete thyroid surgery or a surgical operation within the past 6 months, and also&#xD;
             the patients taking oral anti-diabetic medication, insulin, steroids, thiazide,&#xD;
             anti-psychotics and immuno-suppressive medicines affecting the levels of blood&#xD;
             glucose, insulin and IR, smokers and those consuming alcohol were excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uşak University</investigator_affiliation>
    <investigator_full_name>Cevdet Duran</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
    <mesh_term>Autoantibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04406779
org study id: UsakU-Cevdet1
nct id: NCT04406779
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Breast cancer and thyroid disorders are important health challenges commonly encountered in
      women. The relationship between both conditions still remains unknown. In this study, the
      frequency of thyroid diseases was investigated in breast cancer patients
observational model: Case-Control
time perspective: Prospective
measure: to investigate the frequency of thyroid diseases in breast cancer patients.
time frame: 1 year
arm group label: Patients with breast cancer
description: Patients with breast cancer
arm group label: Control
description: Healthy patients without breast cancer
intervention type: Device
intervention name: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies
description: thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies
arm group label: Control
arm group label: Patients with breast cancer
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
responsible party type: Principal Investigator
investigator affiliation: Uşak University
investigator full name: Cevdet Duran
investigator title: M.D.
mesh term: Breast Neoplasms
mesh term: Thyroid Diseases
mesh term: Hormones
mesh term: Autoantibodies
sharing ipd: No