<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/NCT04429269</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-MUSD</org_study_id>
    <nct_id>NCT04429269</nct_id>
  </id_info>
  <brief_title>A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis</brief_title>
  <acronym>MUSD</acronym>
  <official_title>A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the&#xD;
      main tool for screening early breast cancer, the characteristics of dense breast and young&#xD;
      onset of disease in Chinese women lowers the efficiency. The aim of this prospective study&#xD;
      was to compare which method, x-ray or ultrasound, is more appropriate for screening and early&#xD;
      diagnosis of breast cancer in Chinese women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer has become the most common malignancy in women. Improving the early diagnosis&#xD;
      of breast cancer can reduce mortality. Mammography is recommended as the main tool for&#xD;
      screening and early diagnosis of breast cancer in the guidelines of European and American&#xD;
      countries. However, the characteristics of dense breast and young onset of disease in Chinese&#xD;
      women make the screening and early diagnosis strategies of Western countries, which are&#xD;
      mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study&#xD;
      was to compare which method, x-ray or ultrasound, is more appropriate for screening and early&#xD;
      diagnosis of breast cancer in Chinese women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>screening yield</measure>
    <time_frame>3 years</time_frame>
    <description>The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness</measure>
    <time_frame>3 years</time_frame>
    <description>The cost-effectiveness of each screening modality to detect one case of breast cancer</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Breast Cancer Diagnosis</condition>
  <condition>Breast Cancer Screening</condition>
  <arm_group>
    <arm_group_label>mammography and ultrasound</arm_group_label>
    <description>mammography and ultrasound screening</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>mammography and ultrasound screening</intervention_name>
    <description>Patients screened by both mammography and ultrasound.</description>
    <arm_group_label>mammography and ultrasound</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsy or specimen from volunteers or donors are planned to be collected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo&#xD;
        ultrasound and X-rays&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound&#xD;
             and x-ray&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Localized breast erythema and ulceration, pregnancy, lactation, after previous breast&#xD;
             implantation, already pathologically definite breast cancer patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Songjie Shen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Songjie Shen, MD</last_name>
    <phone>(010) 6915 8721</phone>
    <email>shensj@pumch.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Songjie Shen, MD</last_name>
      <phone>010 6915 8721</phone>
      <email>shensj@pumch.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mammography</keyword>
  <keyword>ultrasound</keyword>
  <keyword>breast cancer screening</keyword>
  <keyword>early diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual information of each participant of the trials is not shown in public, yet can be obtained upon reasonable requirements.</ipd_description>
  </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/NCT04429269
org study id: PUMCH-MUSD
nct id: NCT04429269
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the
      main tool for screening early breast cancer, the characteristics of dense breast and young
      onset of disease in Chinese women lowers the efficiency. The aim of this prospective study
      was to compare which method, x-ray or ultrasound, is more appropriate for screening and early
      diagnosis of breast cancer in Chinese women.
Breast cancer has become the most common malignancy in women. Improving the early diagnosis
      of breast cancer can reduce mortality. Mammography is recommended as the main tool for
      screening and early diagnosis of breast cancer in the guidelines of European and American
      countries. However, the characteristics of dense breast and young onset of disease in Chinese
      women make the screening and early diagnosis strategies of Western countries, which are
      mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study
      was to compare which method, x-ray or ultrasound, is more appropriate for screening and early
      diagnosis of breast cancer in Chinese women.
observational model: Cohort
time perspective: Prospective
measure: screening yield
time frame: 3 years
description: The sensitivity, specificity, positive predictive value, and negative predictive value of the screening methods.
measure: cost-effectiveness
time frame: 3 years
description: The cost-effectiveness of each screening modality to detect one case of breast cancer
arm group label: mammography and ultrasound
description: mammography and ultrasound screening
intervention type: Diagnostic Test
intervention name: mammography and ultrasound screening
description: Patients screened by both mammography and ultrasound.
arm group label: mammography and ultrasound
Biopsy or specimen from volunteers or donors are planned to be collected
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 70 Years
last name: Songjie Shen, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China
last name: Songjie Shen, MD
phone: (010) 6915 8721
email: shensj@pumch.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Disease
sharing ipd: No
ipd description: Individual information of each participant of the trials is not shown in public, yet can be obtained upon reasonable requirements.