<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/NCT03006055</url>
  </required_header>
  <id_info>
    <org_study_id>VIROAD01</org_study_id>
    <nct_id>NCT03006055</nct_id>
  </id_info>
  <brief_title>The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Viroad Biotechnology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Viroad Biotechnology Co., Ltd.</source>
  <brief_summary>
    <textblock>
      The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE&#xD;
      approved. Application data of CellCollector in China is not available now. The purpose of&#xD;
      this clinical trial is to confirm the validation and safety of CellCollector in Chinese&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Validation of CellCollector</measure>
    <time_frame>6 month</time_frame>
    <description>CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 month</time_frame>
    <description>Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Circulating Tumor Cells.Breast</condition>
  <arm_group>
    <arm_group_label>MBC Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>metastatic breast cancer Age：18-75 ECOG:0-2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>benign breast tumour Age：18-75 ECOG:0-2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Circulating tumor cells</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>MBC Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastasis breast cancer confirmed with imaging examination&#xD;
&#xD;
          -  Have agreed to undergo CTC analysis in vivo;&#xD;
&#xD;
          -  ECOG：0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-metastasis breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>YH Dong, MD</last_name>
    <phone>+86031189928691</phone>
    <email>dongyh_viroad@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The 307th Hospital of Chinese People's Liberation Army</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ZF Jiang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplastic Cells, Circulating</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/NCT03006055
org study id: VIROAD01
nct id: NCT03006055
lead sponsor: 
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE
      approved. Application data of CellCollector in China is not available now. The purpose of
      this clinical trial is to confirm the validation and safety of CellCollector in Chinese
      patients.
measure: Validation of CellCollector
time frame: 6 month
description: CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 6 month
description: Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
arm group label: MBC Group
arm group type: Experimental
description: metastatic breast cancer Age：18-75 ECOG:0-2
arm group label: Control Group
arm group type: Experimental
description: benign breast tumour Age：18-75 ECOG:0-2
intervention type: Device
intervention name: Circulating tumor cells
arm group label: Control Group
arm group label: MBC Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: YH Dong, MD
phone: +86031189928691
email: dongyh_viroad@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neoplastic Cells, Circulating