<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/NCT03247478</url>
  </required_header>
  <id_info>
    <org_study_id>BCP20</org_study_id>
    <nct_id>NCT03247478</nct_id>
  </id_info>
  <brief_title>Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure</brief_title>
  <acronym>CTREP</acronym>
  <official_title>Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure: a Prospective Observational Study Evaluating Response in Axillary Lymph Nodes of Breast Cancer After 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>
      The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is&#xD;
      low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to&#xD;
      axillary lymph node. The aim of this study is to determine performance of computed tomography&#xD;
      (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in&#xD;
      breast cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 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, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.</measure>
    <time_frame>within 6 weeks after obtaining the post-surgery pathological results</time_frame>
    <description>Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rreceiver operating characteristic (ROC) curve analysis</measure>
    <time_frame>within 6 weeks after obtaining the post-surgery pathological results</time_frame>
    <description>The diagnostic performance of computed tomography (CT) reconstruction 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="Actual">160</enrollment>
  <condition>Invasive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>invasive breast cancer</arm_group_label>
    <description>Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after 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.</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>
        Invasive breast cancer with axillary lymph node metastasis: stage N1-2.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle&#xD;
             aspiration (FNA) or core needle biopsy (CNB).&#xD;
&#xD;
          -  Underwent computed tomography (CT) reconstruction for assessment of axillary lymph&#xD;
             node status before and after neoadjuvant chemotherapy (NAC).&#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>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-ze Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</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>Computed tomography (CT) reconstruction</keyword>
  <keyword>axillary lymph node status</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/NCT03247478
org study id: BCP20
nct id: NCT03247478
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.
The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is
      low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to
      axillary lymph node. The aim of this study is to determine performance of computed tomography
      (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in
      breast cancer patients.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.
time frame: within 6 weeks after obtaining the post-surgery pathological results
description: Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed.
measure: Rreceiver operating characteristic (ROC) curve analysis
time frame: within 6 weeks after obtaining the post-surgery pathological results
description: The diagnostic performance of computed tomography (CT) reconstruction 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: invasive breast cancer
description: Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after 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.
Axillary lymph node status are determined in FNA/CNB and surgical specimen.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Li-ze Wang, MD
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
facility: 
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