<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/NCT04457700</url>
  </required_header>
  <id_info>
    <org_study_id>BCP28</org_study_id>
    <nct_id>NCT04457700</nct_id>
  </id_info>
  <brief_title>CT-based Radiomics of ALN pCR (ypN0) in Breast Cancer Undergoing NAC</brief_title>
  <official_title>Computed Tomography-based Radiomics of Axillary Lymph Node Pathological Complete Remission (ypN0) in Breast Cancer Undergoing Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</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>
      This is a prospective, single-center, non-randomized, non-controlled observational study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2&#xD;
      (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete&#xD;
      remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is&#xD;
      paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We&#xD;
      found that patients with normal-appearing lymph nodes on computed tomography (CT) based&#xD;
      radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal&#xD;
      disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been&#xD;
      established yet. This study aimed to assess the performance of CT-based radiomics in&#xD;
      evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast&#xD;
      cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2022</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>The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy</measure>
    <time_frame>within 8 weeks after obtaining the post-surgery pathological results</time_frame>
    <description>Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of CT-based radiomics for axillary lymph node status after neoadjuvant chemotherapy will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receiver operating characteristic (ROC) curve analysis</measure>
    <time_frame>within 8 weeks after obtaining the post-surgery pathological results</time_frame>
    <description>The diagnostic performance of CT-based radiomics for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">218</enrollment>
  <condition>Triple-negative Breast Cancer</condition>
  <condition>HER2-positive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Triple-negative and HER2 Positive breast cancer</arm_group_label>
    <description>Patients with triple-negative or HER2 Positive breast cancer, axillary lymph node metastasis who underwent NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. CT-based radiomics will be uesd in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Axillary lymph node status are determined in FNA/CNB and surgical specimen.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis:&#xD;
        stage T1-3N1-2M0.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Triple-negative or HER2-positve invasive breast cancer with axillary lymph node&#xD;
             metastasis by confirmed by fine needle aspiration or core needle biopsy.&#xD;
&#xD;
          -  Underwent computed tomography for assessment of axillary lymph node status before and&#xD;
             after neoadjuvant chemotherapy.&#xD;
&#xD;
          -  Attend the study voluntarily, sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contradiction for adjuvant chemotherapy.&#xD;
&#xD;
          -  Contradiction for proceeding surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lize Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Breast center at Peking University Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lize Wang, MD</last_name>
    <phone>+86-10-88271119</phone>
    <phone_ext>5001</phone_ext>
    <email>lize2010@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yingjian He, MD</last_name>
    <phone>+86-10-88271119</phone>
    <phone_ext>8018</phone_ext>
    <email>mimi487@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lize Wang, MD</last_name>
      <phone>+86-10-88271119</phone>
      <phone_ext>8018</phone_ext>
      <email>lize2010@163.com</email>
    </contact>
    <investigator>
      <last_name>Lize Wang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jiwei Wang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Tao OUYANG</investigator_full_name>
    <investigator_title>Director of Breast Center of Peking University Cancer Hospital</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Neoadjuvant chemotherapy</keyword>
  <keyword>Lymph node</keyword>
  <keyword>Radiomic</keyword>
  <keyword>Pathologic complete remission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04457700
org study id: BCP28
nct id: NCT04457700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, single-center, non-randomized, non-controlled observational study.
Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2
      (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete
      remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is
      paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We
      found that patients with normal-appearing lymph nodes on computed tomography (CT) based
      radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal
      disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been
      established yet. This study aimed to assess the performance of CT-based radiomics in
      evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast
      cancer patients.
observational model: Cohort
time perspective: Prospective
measure: The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy
time frame: within 8 weeks after obtaining the post-surgery pathological results
description: Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of CT-based radiomics for axillary lymph node status after neoadjuvant chemotherapy will be assessed.
measure: Receiver operating characteristic (ROC) curve analysis
time frame: within 8 weeks after obtaining the post-surgery pathological results
description: The diagnostic performance of CT-based radiomics for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve
arm group label: Triple-negative and HER2 Positive breast cancer
description: Patients with triple-negative or HER2 Positive breast cancer, axillary lymph node metastasis who underwent NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. CT-based radiomics will be uesd in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.
Axillary lymph node status are determined in FNA/CNB and surgical specimen.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Lize Wang, MD
role: Principal Investigator
affiliation: Breast center at Peking University Cancer Hospital
last name: Lize Wang, MD
phone: +86-10-88271119
phone ext: 5001
email: lize2010@163.com
last name: Yingjian He, MD
phone: +86-10-88271119
phone ext: 8018
email: mimi487@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Tao OUYANG
investigator title: Director of Breast Center of Peking University Cancer Hospital
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
sharing ipd: Undecided