<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/NCT03762642</url>
  </required_header>
  <id_info>
    <org_study_id>357-71</org_study_id>
    <nct_id>NCT03762642</nct_id>
  </id_info>
  <brief_title>Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients</brief_title>
  <official_title>Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz 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 is the most common cancer in women across the world, accounting for 25.2% of&#xD;
      cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The&#xD;
      survival rates are markedly lower in the developing countries compared to developed&#xD;
      countries, as well as the age at diagnosis. Core management of breast cancer includes&#xD;
      surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy&#xD;
      (removal of the whole breast). Choosing between these two procedures may be influenced by&#xD;
      factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the&#xD;
      prevalence of BCS and mastectomy and the factors that may influence the choice of procedure.&#xD;
      This retrospective study was carried out by reviewing the records of female breast cancer&#xD;
      patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009&#xD;
      to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence.&#xD;
      Using frequencies for the rate, and multivariate tests, the investigators analyzed different&#xD;
      demographic, clinicopathological, and radiological factors to detect correlations with&#xD;
      procedure choice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">August 2, 2018</completion_date>
  <primary_completion_date type="Actual">August 2, 2018</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>Prevalence of each of mastectomy and breast-conserving surgery</measure>
    <time_frame>2009-2017</time_frame>
    <description>The percentage of of patients who underwent each surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the patients' age (in years)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using independent sample T-test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the use of preoperative chemotherapy (also called &quot;neoadjuvant chemotherapy&quot;)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's size (in centimeters)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using independent sample T-test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's stage (using the 7th &quot;American Joint Committee on Cancer&quot;'s staging guidelines)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings</measure>
    <time_frame>2009-2017</time_frame>
    <description>Statistical analysis using Chi-square test and binary logistic regression</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">335</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Breast Neoplasms</condition>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Mastectomy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast-Conserving Surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mastectomy</intervention_name>
    <description>Removal of the whole breast</description>
    <arm_group_label>Mastectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Breast-Conserving Surgery</intervention_name>
    <description>Removal of the cancerous tissue only</description>
    <arm_group_label>Breast-Conserving Surgery</arm_group_label>
    <other_name>Lumpectomy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Female breast cancer patients who underwent surgery for breast cancer in King Abdulaziz&#xD;
        University hospital between 2009 and June 2017 excluding those who had metastasis or&#xD;
        recurrence before the surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King&#xD;
             Abdulaziz University Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic breast cancer or recurrence of the cancer before the surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Jeddah</city>
        <state>Mecca</state>
        <zip>00966</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Zuhoor K. AL-Sharif</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer Surgery</keyword>
  <keyword>Lumpectomy</keyword>
  <keyword>Surgery Choice</keyword>
  <keyword>Procedure Choice</keyword>
  <keyword>Surgical Outcome</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/NCT03762642
org study id: 357-71
nct id: NCT03762642
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Breast cancer is the most common cancer in women across the world, accounting for 25.2% of
      cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The
      survival rates are markedly lower in the developing countries compared to developed
      countries, as well as the age at diagnosis. Core management of breast cancer includes
      surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy
      (removal of the whole breast). Choosing between these two procedures may be influenced by
      factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the
      prevalence of BCS and mastectomy and the factors that may influence the choice of procedure.
      This retrospective study was carried out by reviewing the records of female breast cancer
      patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009
      to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence.
      Using frequencies for the rate, and multivariate tests, the investigators analyzed different
      demographic, clinicopathological, and radiological factors to detect correlations with
      procedure choice.
observational model: Cohort
time perspective: Retrospective
measure: Prevalence of each of mastectomy and breast-conserving surgery
time frame: 2009-2017
description: The percentage of of patients who underwent each surgery
measure: The relationship between the choice of procedure and the patients' age (in years)
time frame: 2009-2017
description: Statistical analysis using independent sample T-test and binary logistic regression
measure: The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's size (in centimeters)
time frame: 2009-2017
description: Statistical analysis using independent sample T-test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
measure: The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings
time frame: 2009-2017
description: Statistical analysis using Chi-square test and binary logistic regression
arm group label: Mastectomy
arm group label: Breast-Conserving Surgery
intervention type: Procedure
intervention name: Mastectomy
description: Removal of the whole breast
arm group label: Mastectomy
intervention type: Procedure
intervention name: Breast-Conserving Surgery
description: Removal of the cancerous tissue only
arm group label: Breast-Conserving Surgery
other name: Lumpectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Zuhoor K. AL-Sharif
investigator title: Professor
mesh term: Breast Neoplasms