<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/NCT03280134</url>
  </required_header>
  <id_info>
    <org_study_id>ZJCH-CK19B</org_study_id>
    <nct_id>NCT03280134</nct_id>
  </id_info>
  <brief_title>A Prospective Validation Cohort Study of a Prediction System on nSLN Metastasis in Early Breast Cancer</brief_title>
  <official_title>CK19 Combined With Contrast-enhanced Ultrasound for Predicting Non-sentinel Lymph Node Status in Early Breast Cancer: a Prospectively Validation Cohort Study of the Predictive Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer Hospital</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>
      In the previous study, the investigator established a predictive model for non-sentinel lymph&#xD;
      node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the&#xD;
      clinical value of the model, the investigator design a prospectively research using the model&#xD;
      guiding for further axillary lymph node dissection in SLN-positve early breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the previous study, a predictive model for non-sentinel lymph node involvement in early&#xD;
      breast cancer (cT1-2cN0, 1-2 SLNs involvement) was established. This model was designed for&#xD;
      predicting the status of non-sentinel lymph node in cT1-2cN0 with 1-2 SLNs involvement breast&#xD;
      cancer based on peripheral blood CK19 and contrast-enhanced ultrasound. The investigator&#xD;
      previously tested this model comparing with MSKCC model in a same population and confirmed a&#xD;
      result of satisfactory low false-negative rate and high AUC. This model had a potential&#xD;
      practise value in clinic applying. For further validation, the research group design the&#xD;
      CK19B trial to prospectively using this model in decision strategy of whether receiving ALND&#xD;
      in 1-2SLNs+ patients. If the model predictive result is negative, the risk of nSLNs&#xD;
      involvement is estimated very low and the patients should be avoid ALND, even radiotherapy no&#xD;
      matter the surgery is mastectomy or conserving. If the model result is positive, then further&#xD;
      ALND or radiotherapy should be accepted by patients to decrease the risk of local and&#xD;
      regional recurrent. A prospectively and conditional grouping method is planned for this&#xD;
      cohort study. The primary endpoint is disease-free survival (DFS) in two groups, the second&#xD;
      primary endpoint is local recurrent rate (LRR) and overall survival (OS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study based on prospective cohort method and concerning on the two groups (whether ALND or not) by predictive model nSLN results.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease-free survival (DFS)</measure>
    <time_frame>3-year(mid-term) 5-year</time_frame>
    <description>The time from enrollment to the first recurrent or metastasis event</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>local recurrent rate</measure>
    <time_frame>3-year(mid-term) 5-year</time_frame>
    <description>The time from enrollment to the first time of local recurrent event (lymph drainage area recurrence)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overal survival (OS)</measure>
    <time_frame>3-year(mid-term) 5-year</time_frame>
    <description>The time from enrollment to death for any reason</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">388</enrollment>
  <condition>Lymph Node Metastases</condition>
  <condition>Breast Cancer</condition>
  <condition>Predictive Cancer Model</condition>
  <arm_group>
    <arm_group_label>predictive nSLN-</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No further axillary lymph node dissection (ALND)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>predictive nSLN+</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>axillary lymph node dissection (ALND)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>axillary lymph node dissection (ALND)</intervention_name>
    <description>If the patients had predictive nSLN+, need further axillary lymph node dissection.</description>
    <arm_group_label>predictive nSLN+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        the test group should be in accordance with the pathological diagnosis of breast cancer,&#xD;
        the clinical stage of breast cancer (stage cTis, cI, cII and cT3N1M0), the initial&#xD;
        treatment to receive surgical treatment. Complete preoperative clinical diagnosis data,&#xD;
        including the ipsilateral axillary lymph node CEUS data and peripheral blood sample; The&#xD;
        negative-control group should comply with the pathological diagnosis, breast adenosis,&#xD;
        fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative&#xD;
        clinical data, also including ipsilateral axillary lymph node CEUS data and peripheral&#xD;
        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>XF YU, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>XF YU, M.D.</last_name>
    <phone>+8657188122001</phone>
    <email>yuxf1177@zjcc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xing-Fei YU, MD.</last_name>
      <email>yhjzlyy@163.com</email>
    </contact>
    <investigator>
      <last_name>Xing-Fei YU, MD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>June 2, 2019</last_update_submitted>
  <last_update_submitted_qc>June 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 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>Dr.</investigator_title>
  </responsible_party>
  <keyword>non-sentinel lymph node</keyword>
  <keyword>breast cancer</keyword>
  <keyword>prediction</keyword>
  <keyword>CK19</keyword>
  <keyword>contrast-enhanced ultrasound</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>
  <!-- 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/NCT03280134
org study id: ZJCH-CK19B
nct id: NCT03280134
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the previous study, the investigator established a predictive model for non-sentinel lymph
      node involvement in early breast cancer (cT1-2cN0, 1-2 SLNs involvement). To validation the
      clinical value of the model, the investigator design a prospectively research using the model
      guiding for further axillary lymph node dissection in SLN-positve early breast cancer.
In the previous study, a predictive model for non-sentinel lymph node involvement in early
      breast cancer (cT1-2cN0, 1-2 SLNs involvement) was established. This model was designed for
      predicting the status of non-sentinel lymph node in cT1-2cN0 with 1-2 SLNs involvement breast
      cancer based on peripheral blood CK19 and contrast-enhanced ultrasound. The investigator
      previously tested this model comparing with MSKCC model in a same population and confirmed a
      result of satisfactory low false-negative rate and high AUC. This model had a potential
      practise value in clinic applying. For further validation, the research group design the
      CK19B trial to prospectively using this model in decision strategy of whether receiving ALND
      in 1-2SLNs+ patients. If the model predictive result is negative, the risk of nSLNs
      involvement is estimated very low and the patients should be avoid ALND, even radiotherapy no
      matter the surgery is mastectomy or conserving. If the model result is positive, then further
      ALND or radiotherapy should be accepted by patients to decrease the risk of local and
      regional recurrent. A prospectively and conditional grouping method is planned for this
      cohort study. The primary endpoint is disease-free survival (DFS) in two groups, the second
      primary endpoint is local recurrent rate (LRR) and overall survival (OS).
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This study based on prospective cohort method and concerning on the two groups (whether ALND or not) by predictive model nSLN results.
primary purpose: Treatment
masking: None (Open Label)
measure: disease-free survival (DFS)
time frame: 3-year(mid-term) 5-year
description: The time from enrollment to the first recurrent or metastasis event
measure: local recurrent rate
time frame: 3-year(mid-term) 5-year
description: The time from enrollment to the first time of local recurrent event (lymph drainage area recurrence)
measure: overal survival (OS)
time frame: 3-year(mid-term) 5-year
description: The time from enrollment to death for any reason
arm group label: predictive nSLN-
arm group type: No Intervention
description: No further axillary lymph node dissection (ALND)
arm group label: predictive nSLN+
arm group type: Active Comparator
description: axillary lymph node dissection (ALND)
intervention type: Procedure
intervention name: axillary lymph node dissection (ALND)
description: If the patients had predictive nSLN+, need further axillary lymph node dissection.
arm group label: predictive nSLN+
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: XF YU, M.D.
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
last name: XF YU, M.D.
phone: +8657188122001
email: yuxf1177@zjcc.org.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhejiang Cancer Hospital
investigator full name: YU Xingfei
investigator title: Dr.
mesh term: Breast Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Lymphatic Metastasis