<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/NCT04483804</url>
  </required_header>
  <id_info>
    <org_study_id>SAHZhejiangU---Breast</org_study_id>
    <nct_id>NCT04483804</nct_id>
  </id_info>
  <brief_title>Application of Radiomics in Breast Cancer</brief_title>
  <official_title>Application of Radiomics in Correlation Between Ultrasound Characteristics and Pathological Prognostic Factors in Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
      Little is known about the correlation between ultrasound characteristics (conventional,&#xD;
      elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in&#xD;
      breast cancer. The aim of this study was to explore the correlation between ultrasound&#xD;
      characteristics and pathological prognostic factors using radiomics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>metastasis</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>lymph node metastasis and/or distant metastasis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>death</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Ultrasound</condition>
  <condition>Elastography</condition>
  <condition>Pathology</condition>
  <condition>Radiomics</condition>
  <arm_group>
    <arm_group_label>disease free survival</arm_group_label>
    <description>Time from randomization to relapse or death due to disease progression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-disease free survival</arm_group_label>
    <description>Time of metastasis or death</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Endocrine therapy</intervention_name>
    <description>Endocrine therapy</description>
    <arm_group_label>disease free survival</arm_group_label>
    <arm_group_label>non-disease free survival</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Missing pathology Missing follow-up results Missing data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female dominated</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>pintong Huang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zimei Lin</last_name>
    <phone>+8615157171799</phone>
    <email>zimei.lin@zju.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>jifan Chen</last_name>
    <phone>+8613605771565</phone>
    <email>jifanchen@zju.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>the Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>zimei Lin</last_name>
      <phone>+86151517171799</phone>
      <email>zimei.lin@zju.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>jifan Chen</last_name>
      <phone>+8613605771565</phone>
      <email>jifanchen@zju.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>individual participant data (IPD) can be shared after the main unit publish articles</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>by request</ipd_time_frame>
    <ipd_access_criteria>by request</ipd_access_criteria>
  </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/NCT04483804
org study id: SAHZhejiangU---Breast
nct id: NCT04483804
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Little is known about the correlation between ultrasound characteristics (conventional,
      elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in
      breast cancer. The aim of this study was to explore the correlation between ultrasound
      characteristics and pathological prognostic factors using radiomics.
observational model: Cohort
time perspective: Prospective
measure: metastasis
time frame: through study completion, an average of 1 year
description: lymph node metastasis and/or distant metastasis
measure: death
time frame: through study completion, an average of 1 year
description: death
arm group label: disease free survival
description: Time from randomization to relapse or death due to disease progression
arm group label: non-disease free survival
description: Time of metastasis or death
intervention type: Combination Product
intervention name: Endocrine therapy
description: Endocrine therapy
arm group label: disease free survival
arm group label: non-disease free survival
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Female dominated
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: pintong Huang
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: zimei Lin
phone: +8615157171799
email: zimei.lin@zju.edu.cn
last name: jifan Chen
phone: +8613605771565
email: jifanchen@zju.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: individual participant data (IPD) can be shared after the main unit publish articles
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: by request
ipd access criteria: by request