<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/NCT02992067</url>
  </required_header>
  <id_info>
    <org_study_id>ZJCH-CK19A</org_study_id>
    <nct_id>NCT02992067</nct_id>
  </id_info>
  <brief_title>CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer</brief_title>
  <acronym>CK-CEUS</acronym>
  <official_title>CK19 Combined With Contrast-enhanced Ultrasound: a Prediction System on Axillary Lymph Node Metastasis in Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang Cancer Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish a predicting system on axillary lymph node metastasis based on peripheral blood&#xD;
      CK19mRNA and contrast-enhanced ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The feasibility and predictive accuracy of peripheral blood CK19mRNA and contrast-enhanced&#xD;
      ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of&#xD;
      specimen bank; to establish the evaluation system of predicting the lymph node status based&#xD;
      on CK19 and CEUS, validate the sensitivity, specificity, negative predictive value, positive&#xD;
      predictive value and ROC curve of the system model and use Youden index, negative likelihood&#xD;
      ratio, positive likelihood ratio to evaluate the diagnostic efficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node</measure>
    <time_frame>1 year</time_frame>
    <description>The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">359</enrollment>
  <condition>Lymph Node</condition>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>Operable breast cancer</arm_group_label>
    <description>clinical stage: cTis, cI, cII, cT3N1M0</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Operable breast cancer patients (clinical stage: cTis, cI, cII, cT3N1M0)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female, age 18~70 years old&#xD;
&#xD;
          2. the test group should be in accordance with the pathological diagnosis of breast&#xD;
             cancer, the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the&#xD;
             initial treatment to receive surgical treatment. Complete preoperative clinical&#xD;
             diagnosis data, including the ipsilateral axillary lymph node CEUS data and peripheral&#xD;
             blood sample; The negative-control group should comply with the pathological&#xD;
             diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign&#xD;
             lesions, with complete preoperative clinical data, also including ipsilateral axillary&#xD;
             lymph node CEUS data and peripheral blood sample&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. metastatic breast cancer, inflammatory breast disease, surgery without lymph node&#xD;
             staging&#xD;
&#xD;
          2. pregnancy or lactation&#xD;
&#xD;
          3. patients with hematopoietic system disease or cancer, autoimmune diseases&#xD;
&#xD;
          4. preservation of substandard peripheral blood samples.&#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>Xingfei Yu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>June 2, 2019</results_first_submitted>
  <results_first_submitted_qc>September 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 4, 2019</results_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang Cancer Hospital</investigator_affiliation>
    <investigator_full_name>YU Xingfei</investigator_full_name>
    <investigator_title>Breast Tumor Surgery (Department 104)</investigator_title>
  </responsible_party>
  <keyword>lymph node metastasis</keyword>
  <keyword>breast cancer</keyword>
  <keyword>CK19</keyword>
  <keyword>contrast-enhanced ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Lymphatic Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02992067/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Operable Breast Cancer</title>
          <description>clinical stage: cTis, cI, cII, cT3N1M0</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="359"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="359"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Operable Breast Cancer</title>
          <description>clinical stage: cTis, cI, cII, cT3N1M0</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="359"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.88" spread="9.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lymph node involvement</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node</title>
        <description>The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Operable Breast Cancer</title>
            <description>clinical stage: cTis, cI, cII, cT3N1M0</description>
          </group>
        </group_list>
        <measure>
          <title>The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node</title>
          <description>The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination</description>
          <units>proportion of false negative lymphnodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="359"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Operable Breast Cancer</title>
          <description>clinical stage: cTis, cI, cII, cT3N1M0</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="359"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="359"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Yu Xingfei</name_or_title>
      <organization>Zhejiang Cancer Hospital</organization>
      <phone>057188122001 ext +86</phone>
      <email>yuxf1177@zjcc.org.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02992067
org study id: ZJCH-CK19A
nct id: NCT02992067
lead sponsor: 
collaborator: 
has dmc: Yes
To establish a predicting system on axillary lymph node metastasis based on peripheral blood
      CK19mRNA and contrast-enhanced ultrasound.
The feasibility and predictive accuracy of peripheral blood CK19mRNA and contrast-enhanced
      ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of
      specimen bank; to establish the evaluation system of predicting the lymph node status based
      on CK19 and CEUS, validate the sensitivity, specificity, negative predictive value, positive
      predictive value and ROC curve of the system model and use Youden index, negative likelihood
      ratio, positive likelihood ratio to evaluate the diagnostic efficiency.
observational model: Case-Control
time perspective: Prospective
measure: The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node
time frame: 1 year
description: The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination
arm group label: Operable breast cancer
description: clinical stage: cTis, cI, cII, cT3N1M0
peripheral blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xingfei Yu, M.D.
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhejiang Cancer Hospital
investigator full name: YU Xingfei
investigator title: Breast Tumor Surgery (Department 104)
mesh term: Breast Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Lymphatic Metastasis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 