<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/NCT03791840</url>
  </required_header>
  <id_info>
    <org_study_id>PKUPHUS002</org_study_id>
    <nct_id>NCT03791840</nct_id>
  </id_info>
  <brief_title>The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS</brief_title>
  <acronym>NI-RADS</acronym>
  <official_title>The Accuracy of High-resolution Ultrasound in the Detection of Lymph Node Metastasis From Breast Cancer and the Proposal of Node Imaging Reporting and Data System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The status of axillary lymph node (ALN) is an important reference indicator for breast cancer&#xD;
      surgery and systemic treatment, which is also an important prognostic indicator for breast&#xD;
      cancer. Therefore, it is extremely important for surgeons to accurately determine whether&#xD;
      axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of&#xD;
      ultrasound diagnosing the status of axillary lymph nodes was controversial in recent&#xD;
      publications. Therefore, there is a high need to prove the accuracy and precision of&#xD;
      ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this&#xD;
      study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node&#xD;
      status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters&#xD;
      to build a clinical useful categorization system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To facilitate the non-invasive assessment of lymph node status preoperatively, we use&#xD;
      ultrasound to detect lymph node metastasis. We designed this study to obtain in vivo and&#xD;
      vitro ultrasound features and parameters. Before surgery, the detailed ultrasound features&#xD;
      are collected during routine ultrasound examination. After the completion of the axillary&#xD;
      surgery, fresh lymph node specimens are collected for in vitro ultrasound evaluation one by&#xD;
      one in a specially-designed detection system. Statistical models are built to categorize the&#xD;
      probability of metastasis of lymph node according to a proposed categorization system similar&#xD;
      as BI-RADS(Breast Imaging Reporting and Data System), which is named NI-RADS (Node Imaging&#xD;
      Reporting and Data System).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Sensitivity of ultrasound</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>True positive rate measures the proportion of positives that are correctly identified by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity of ultrasound</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The true negative rate measures the proportion of negatives that are correctly identified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic model of lymph node ultrasound</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>A diagnostic model or nomogram would be developed to facilitate the diagnosis of the lymph node ultrasound.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">135</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Ultrasound evaluation</arm_group_label>
    <description>Eligible patients undergo lymph node biopsy or lymph node dissection. Before surgery, the status of axillary lymph node status was evaluated using ultrasound. After surgery, all lymph node specimens would be collected and be assessed using ultrasound in a special evaluation system in vitro.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound evaluation</intervention_name>
    <description>High-frequency ultrasound is used to detected the lymph node metastasis in vivo and vitro. The lymph node number, morphology and elastographic parameters are collected in the patients and in fresh lymph node specimens.</description>
    <arm_group_label>Ultrasound evaluation</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fresh lymph node specimens from breast cancer patients were detected using ultrasound.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with invasive breast cancer planned to receive surgical axillary lymph node&#xD;
        staging are eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed invasive breast cancer.&#xD;
&#xD;
          -  Pathological axillary lymph node staging planned.&#xD;
&#xD;
          -  Axillary lymph node not removed prior to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>10044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Han P, Yang H, Liu M, Cheng L, Wang S, Tong F, Liu P, Zhou B, Cao Y, Liu H, Wang C, Peng Y, Shen D, Wang S. Lymph Node Predictive Model with in Vitro Ultrasound Features for Breast Cancer Lymph Node Metastasis. Ultrasound Med Biol. 2020 Jun;46(6):1395-1402. doi: 10.1016/j.ultrasmedbio.2020.01.030. Epub 2020 Mar 5.</citation>
    <PMID>32146007</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>October 14, 2022</last_update_submitted>
  <last_update_submitted_qc>October 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>HP Yang</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>breast neoplasms</keyword>
  <keyword>Ultrasonography, Interventional</keyword>
  <keyword>Biopsy, Large-Core Needle</keyword>
  <keyword>Biopsy, Fine-Needle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</mesh_term>
  </condition_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/NCT03791840
org study id: PKUPHUS002
nct id: NCT03791840
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The status of axillary lymph node (ALN) is an important reference indicator for breast cancer
      surgery and systemic treatment, which is also an important prognostic indicator for breast
      cancer. Therefore, it is extremely important for surgeons to accurately determine whether
      axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of
      ultrasound diagnosing the status of axillary lymph nodes was controversial in recent
      publications. Therefore, there is a high need to prove the accuracy and precision of
      ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this
      study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node
      status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters
      to build a clinical useful categorization system
To facilitate the non-invasive assessment of lymph node status preoperatively, we use
      ultrasound to detect lymph node metastasis. We designed this study to obtain in vivo and
      vitro ultrasound features and parameters. Before surgery, the detailed ultrasound features
      are collected during routine ultrasound examination. After the completion of the axillary
      surgery, fresh lymph node specimens are collected for in vitro ultrasound evaluation one by
      one in a specially-designed detection system. Statistical models are built to categorize the
      probability of metastasis of lymph node according to a proposed categorization system similar
      as BI-RADS(Breast Imaging Reporting and Data System), which is named NI-RADS (Node Imaging
      Reporting and Data System).
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of ultrasound
time frame: Through study completion, an average of 1 year.
description: True positive rate measures the proportion of positives that are correctly identified by ultrasound
measure: Specificity of ultrasound
time frame: Through study completion, an average of 1 year.
description: The true negative rate measures the proportion of negatives that are correctly identified.
measure: Diagnostic model of lymph node ultrasound
time frame: Through study completion, an average of 1 year
description: A diagnostic model or nomogram would be developed to facilitate the diagnosis of the lymph node ultrasound.
arm group label: Ultrasound evaluation
description: Eligible patients undergo lymph node biopsy or lymph node dissection. Before surgery, the status of axillary lymph node status was evaluated using ultrasound. After surgery, all lymph node specimens would be collected and be assessed using ultrasound in a special evaluation system in vitro.
intervention type: Diagnostic Test
intervention name: Ultrasound evaluation
description: High-frequency ultrasound is used to detected the lymph node metastasis in vivo and vitro. The lymph node number, morphology and elastographic parameters are collected in the patients and in fresh lymph node specimens.
arm group label: Ultrasound evaluation
Fresh lymph node specimens from breast cancer patients were detected using ultrasound.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Shu Wang, MD
role: Principal Investigator
affiliation: Peking University People's Hospital
facility: 
country: China
citation: Han P, Yang H, Liu M, Cheng L, Wang S, Tong F, Liu P, Zhou B, Cao Y, Liu H, Wang C, Peng Y, Shen D, Wang S. Lymph Node Predictive Model with in Vitro Ultrasound Features for Breast Cancer Lymph Node Metastasis. Ultrasound Med Biol. 2020 Jun;46(6):1395-1402. doi: 10.1016/j.ultrasmedbio.2020.01.030. Epub 2020 Mar 5.
PMID: 32146007
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: HP Yang
investigator title: Clinical Professor
mesh term: Breast Neoplasms
mesh term: Lymphatic Metastasis
sharing ipd: No