<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/NCT03013868</url>
  </required_header>
  <id_info>
    <org_study_id>MiC-SRS-CRC-001</org_study_id>
    <nct_id>NCT03013868</nct_id>
  </id_info>
  <brief_title>CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System</brief_title>
  <official_title>CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MiCareo Taiwan Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MiCareo Taiwan Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the growing public awareness and recent progress in multimodality therapy to the&#xD;
      colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly&#xD;
      cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant&#xD;
      metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated&#xD;
      with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to&#xD;
      prevent the development of metastasis. Early detection and characterization of CTCs is&#xD;
      therefore important as a potential strategy to monitor the progression of CRC. The current&#xD;
      proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R&#xD;
      system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Disease Free Survival</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Circulating Tumor Cells, CTC</condition>
  <eligibility>
    <study_pop>
      <textblock>
        200 Colorectal cancer stage II/III patients who will undergo surgical resection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over 20 and less than 90 years of age.&#xD;
&#xD;
          2. Colorectal cancer stage II/III patients who will undergo surgical resection.&#xD;
&#xD;
          3. Subject having agreed to participate in the study and follow the study procedures by&#xD;
             providing written informed consent prior entering the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have other cancer history.&#xD;
&#xD;
          2. Subject being identified with any blood borne infectious disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wang Henry, Master</last_name>
    <phone>886-2-2796-5096</phone>
    <phone_ext>621</phone_ext>
    <email>henrywang@micareo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</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>
    <mesh_term>Recurrence</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/NCT03013868
org study id: MiC-SRS-CRC-001
nct id: NCT03013868
lead sponsor: 
has dmc: No
Despite the growing public awareness and recent progress in multimodality therapy to the
      colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly
      cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant
      metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated
      with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to
      prevent the development of metastasis. Early detection and characterization of CTCs is
      therefore important as a potential strategy to monitor the progression of CRC. The current
      proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R
      system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.
observational model: Cohort
time perspective: Prospective
measure: Disease Free Survival
time frame: 5 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Wang Henry, Master
phone: 886-2-2796-5096
phone ext: 621
email: henrywang@micareo.com
facility: 
status: Recruiting
country: Taiwan
responsible party type: Sponsor
mesh term: Neoplastic Cells, Circulating
mesh term: Recurrence