<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/NCT03260192</url>
  </required_header>
  <id_info>
    <org_study_id>LQBC020</org_study_id>
    <nct_id>NCT03260192</nct_id>
  </id_info>
  <brief_title>Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer</brief_title>
  <official_title>Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer</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>Yes</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>
      Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to&#xD;
      evaluate patients' response to neoadjuvant chemotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an&#xD;
      inoperable to a resectable tumor.In recent years, it has become an option for patients of&#xD;
      lower tumor stage to increase the possibility of breast conserving therapy. An effective&#xD;
      method to monitor the response to NAC is important.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2013</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2018</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>death of breast cancer</measure>
    <time_frame>Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.</time_frame>
    <description>The event is defined as death of breast cancer, which is a separate measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tumor recurrence or distant metastasis</measure>
    <time_frame>Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.</time_frame>
    <description>The event is defined as breast cancer local recurrence or distant metastasis</description>
  </secondary_outcome>
  <enrollment type="Actual">53</enrollment>
  <condition>Breast Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma separated within 2 hours, stored in -80 celsius refrigerator&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Breast cancer patient receiving NAC in Sunyat-sen memorial hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients undergoing NAC&#xD;
&#xD;
          -  Age: 18-70 yrs&#xD;
&#xD;
          -  Any menopausal status&#xD;
&#xD;
          -  Any hormal receptor status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failed to retain blood sample before NAC&#xD;
&#xD;
          -  Lost more than 2 blood samples during NAC&#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>qiang Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunyat-sen Memorial Hospital</name>
      <address>
        <city>Guandong</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</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>Liu Qiang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>circulating tumor DNA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03260192
org study id: LQBC020
nct id: NCT03260192
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to
      evaluate patients' response to neoadjuvant chemotherapy
Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an
      inoperable to a resectable tumor.In recent years, it has become an option for patients of
      lower tumor stage to increase the possibility of breast conserving therapy. An effective
      method to monitor the response to NAC is important.
observational model: Cohort
time perspective: Prospective
measure: death of breast cancer
time frame: Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.
description: The event is defined as death of breast cancer, which is a separate measure
measure: tumor recurrence or distant metastasis
time frame: Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.
description: The event is defined as breast cancer local recurrence or distant metastasis
plasma separated within 2 hours, stored in -80 celsius refrigerator
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: qiang Liu
role: Principal Investigator
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
investigator full name: Liu Qiang
investigator title: Professor
mesh term: Breast Neoplasms
sharing ipd: Undecided