<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/NCT02992769</url>
  </required_header>
  <id_info>
    <org_study_id>201653</org_study_id>
    <nct_id>NCT02992769</nct_id>
  </id_info>
  <brief_title>Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound</brief_title>
  <official_title>A Nomogram to Predict the Risk of Axillary Metastases in Breast Cancer Patients With Axillary Ultrasound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Axillary lymph node status is a vital prognostic factors in breast cancer patients and&#xD;
      provides crucial information for making treatment decisions.This projective observational&#xD;
      study is planned to identify risk factors for axillary metastases in breast cancer patients&#xD;
      with axillary ultrasound and to construct a nomogram to predict the risk of axillary&#xD;
      metastases in these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast carcinoma is the most common malignancy in women, accounting for 25% of all female&#xD;
      cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a&#xD;
      multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of&#xD;
      patients are pathologically proved to be free from axillary metastasis.The purpose of this&#xD;
      study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool&#xD;
      to support clinical decision-making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>Axillary Metastases</measure>
    <time_frame>4 months to 1.5 year</time_frame>
    <description>Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H&amp;E permanent staining is administered to confirm the results of the frozen section. Serial H&amp;E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H&amp;E staining.</description>
  </primary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Breast Cancer Female</condition>
  <eligibility>
    <study_pop>
      <textblock>
        18 Years to 70 Years (Adult)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients with primary breast cancer&#xD;
&#xD;
          -  receiving a successful SLNB or ALND&#xD;
&#xD;
          -  pathological diagnosed, without distant metastasis&#xD;
&#xD;
          -  a clinically negative axilla&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  neoadjuvant therapy&#xD;
&#xD;
          -  previous ipsilateral axillary surgery&#xD;
&#xD;
          -  inflammatory breast cancer&#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>Fengyan Yu, M.D.,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianguo Lai, M.D.</last_name>
    <phone>0086-15622172952</phone>
    <email>clarkdawson0210@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianguo Lai, M.D</last_name>
      <phone>0086-15622172952</phone>
      <email>clarkdawson0210@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Fengyan Yu, M.D,PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jianguo Lai, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.</citation>
    <PMID>25651787</PMID>
  </reference>
  <reference>
    <citation>Lyman GH, Temin S, Edge SB, Newman LA, Turner RR, Weaver DL, Benson AB 3rd, Bosserman LD, Burstein HJ, Cody H 3rd, Hayman J, Perkins CL, Podoloff DA, Giuliano AE; American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2014 May 1;32(13):1365-83. doi: 10.1200/JCO.2013.54.1177. Epub 2014 Mar 24.</citation>
    <PMID>24663048</PMID>
  </reference>
  <reference>
    <citation>Bevilacqua JL, Kattan MW, Fey JV, Cody HS 3rd, Borgen PI, Van Zee KJ. Doctor, what are my chances of having a positive sentinel node? A validated nomogram for risk estimation. J Clin Oncol. 2007 Aug 20;25(24):3670-9. doi: 10.1200/JCO.2006.08.8013. Epub 2007 Jul 30.</citation>
    <PMID>17664461</PMID>
  </reference>
  <reference>
    <citation>Gentilini O, Veronesi U. Abandoning sentinel lymph node biopsy in early breast cancer? A new trial in progress at the European Institute of Oncology of Milan (SOUND: Sentinel node vs Observation after axillary UltraSouND). Breast. 2012 Oct;21(5):678-81. doi: 10.1016/j.breast.2012.06.013. Epub 2012 Jul 25.</citation>
    <PMID>22835916</PMID>
  </reference>
  <reference>
    <citation>Tucker NS, Cyr AE, Ademuyiwa FO, Tabchy A, George K, Sharma PK, Jin LX, Sanati S, Aft R, Gao F, Margenthaler JA, Gillanders WE. Axillary Ultrasound Accurately Excludes Clinically Significant Lymph Node Disease in Patients With Early Stage Breast Cancer. Ann Surg. 2016 Dec;264(6):1098-1102. doi: 10.1097/SLA.0000000000001549.</citation>
    <PMID>26779976</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 11, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Fengyan Yu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Nomogram</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Axillary Metastases</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>
  </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/NCT02992769
org study id: 201653
nct id: NCT02992769
lead sponsor: 
has dmc: No
Axillary lymph node status is a vital prognostic factors in breast cancer patients and
      provides crucial information for making treatment decisions.This projective observational
      study is planned to identify risk factors for axillary metastases in breast cancer patients
      with axillary ultrasound and to construct a nomogram to predict the risk of axillary
      metastases in these patients.
Breast carcinoma is the most common malignancy in women, accounting for 25% of all female
      cancer cases and 15% of all cancer-related deaths in the world.Lymph node metastasis is a
      multifactorial event. Among patients with a preoperative axillary ultrasound, almost 40% of
      patients are pathologically proved to be free from axillary metastasis.The purpose of this
      study is to develop a nomogram to evaluate the probability of axillary metastasis as a tool
      to support clinical decision-making.
observational model: Cohort
time perspective: Prospective
measure: Axillary Metastases
time frame: 4 months to 1.5 year
description: Surgical treatment for breast cancer patients include breast-conserving surgery or mastectomy with or without breast reconstruction. Intraoperative ALND is carried out when the SLNs are positive by intraoperative frozen section. Post-operative H&E permanent staining is administered to confirm the results of the frozen section. Serial H&E and immunohistochemistry stain (IHC) are only carried out when axillary metastases are not visible after H&E staining.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fengyan Yu, M.D.,Ph.D
role: Principal Investigator
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
last name: Jianguo Lai, M.D.
phone: 0086-15622172952
email: clarkdawson0210@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PMID: 25651787
citation: Lyman GH, Temin S, Edge SB, Newman LA, Turner RR, Weaver DL, Benson AB 3rd, Bosserman LD, Burstein HJ, Cody H 3rd, Hayman J, Perkins CL, Podoloff DA, Giuliano AE; American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2014 May 1;32(13):1365-83. doi: 10.1200/JCO.2013.54.1177. Epub 2014 Mar 24.
PMID: 24663048
citation: Bevilacqua JL, Kattan MW, Fey JV, Cody HS 3rd, Borgen PI, Van Zee KJ. Doctor, what are my chances of having a positive sentinel node? A validated nomogram for risk estimation. J Clin Oncol. 2007 Aug 20;25(24):3670-9. doi: 10.1200/JCO.2006.08.8013. Epub 2007 Jul 30.
PMID: 17664461
citation: Gentilini O, Veronesi U. Abandoning sentinel lymph node biopsy in early breast cancer? A new trial in progress at the European Institute of Oncology of Milan (SOUND: Sentinel node vs Observation after axillary UltraSouND). Breast. 2012 Oct;21(5):678-81. doi: 10.1016/j.breast.2012.06.013. Epub 2012 Jul 25.
PMID: 22835916
citation: Tucker NS, Cyr AE, Ademuyiwa FO, Tabchy A, George K, Sharma PK, Jin LX, Sanati S, Aft R, Gao F, Margenthaler JA, Gillanders WE. Axillary Ultrasound Accurately Excludes Clinically Significant Lymph Node Disease in Patients With Early Stage Breast Cancer. Ann Surg. 2016 Dec;264(6):1098-1102. doi: 10.1097/SLA.0000000000001549.
PMID: 26779976
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
investigator full name: Fengyan Yu
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Neoplasm Metastasis
sharing ipd: No