<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/NCT03295591</url>
  </required_header>
  <id_info>
    <org_study_id>UW17-008</org_study_id>
    <nct_id>NCT03295591</nct_id>
  </id_info>
  <brief_title>Circulating Tumor Cells in mCRC for Liver Resection</brief_title>
  <official_title>Optimizing the Selection of Patients With Metastatic Colorectal Cancer for Liver Resection - An Immuno-clinical Scoring System Incorporating Circulating Tumor Cell Enumeration and Clinical Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resection of liver metastasis is potentially curative in patients with colorectal cancer&#xD;
      bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after&#xD;
      liver resection. To optimize patient selection, the investigators propose to evaluate the the&#xD;
      value of incorporating circulating tumor cells enumeration to clinical factors in a&#xD;
      prospective study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center prospective study to evaluate the predictive value of circulating&#xD;
      tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have&#xD;
      curative resection of liver metastasis. Blood will be taken from patients within 7 days&#xD;
      before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform&#xD;
      for which CTC can be subsequently enumerated with or without sequencing performed. Patients&#xD;
      are then followed up regularly with contrast CT scan for recurrence. The primary study&#xD;
      endpoint is to define the cutoff value of CTC count in patients with early relapse &lt; 6months&#xD;
      after liver resection. Seventy-seven patients will be recruited in 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2019</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>Cutoff value of CTC counts</measure>
    <time_frame>Progression free survival at 6 months</time_frame>
    <description>to identify patients with early relapse (&lt;6 months) after liver resection as determined by the AUC under the ROC curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A immuno-clinical scoring system</measure>
    <time_frame>Progression free survival at 6 months</time_frame>
    <description>A system combining CTC count with clinical factors to stratify patients before liver resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Time from liver resection to date of relapse or date of death, whichever is earlier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Time from liver resection to date of death</description>
  </secondary_outcome>
  <enrollment type="Anticipated">77</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <condition>Circulating Tumor Cell</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Circulating tumor cell</intervention_name>
    <description>Circulating tumor cell enumeration and sequencing</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood in Streck tube will be processed for isolating circulating tumor cells and its DNA&#xD;
      content for subsequent sequencing if feasible&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with colorectal cancer and liver metastasis who are planned for liver resection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age&gt;=18 years&#xD;
&#xD;
          2. Signed informed consent&#xD;
&#xD;
          3. Histologically or cytologically confirmed colorectal adenocarcinoma&#xD;
&#xD;
          4. Both primary tumor and liver metastases are amenable to curative resection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of extrahepatic metastasis&#xD;
&#xD;
          2. History of other malignancies in the last 5 years&#xD;
&#xD;
          3. Patients unable to comply with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka On Lam, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ka On Lam, MBBS</last_name>
    <phone>22554352</phone>
    <email>lamkaon@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ka On Lam, MBBS</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>November 17, 2018</last_update_submitted>
  <last_update_submitted_qc>November 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Lam Ka On</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Metastatic colorectal cancer</keyword>
  <keyword>Liver resection</keyword>
  <keyword>Circulating tumor cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</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/NCT03295591
org study id: UW17-008
nct id: NCT03295591
lead sponsor: 
has dmc: No
Resection of liver metastasis is potentially curative in patients with colorectal cancer
      bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after
      liver resection. To optimize patient selection, the investigators propose to evaluate the the
      value of incorporating circulating tumor cells enumeration to clinical factors in a
      prospective study
This is a single-center prospective study to evaluate the predictive value of circulating
      tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have
      curative resection of liver metastasis. Blood will be taken from patients within 7 days
      before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform
      for which CTC can be subsequently enumerated with or without sequencing performed. Patients
      are then followed up regularly with contrast CT scan for recurrence. The primary study
      endpoint is to define the cutoff value of CTC count in patients with early relapse < 6months
      after liver resection. Seventy-seven patients will be recruited in 24 months.
observational model: Cohort
time perspective: Prospective
measure: Cutoff value of CTC counts
time frame: Progression free survival at 6 months
description: to identify patients with early relapse (<6 months) after liver resection as determined by the AUC under the ROC curve
measure: A immuno-clinical scoring system
time frame: Progression free survival at 6 months
description: A system combining CTC count with clinical factors to stratify patients before liver resection
measure: Progression free survival
time frame: up to 5 years
description: Time from liver resection to date of relapse or date of death, whichever is earlier
measure: Overall survival
time frame: up to 5 years
description: Time from liver resection to date of death
intervention type: Diagnostic Test
intervention name: Circulating tumor cell
description: Circulating tumor cell enumeration and sequencing
blood in Streck tube will be processed for isolating circulating tumor cells and its DNA
      content for subsequent sequencing if feasible
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ka On Lam, MBBS
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Ka On Lam, MBBS
phone: 22554352
email: lamkaon@hku.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Lam Ka On
investigator title: Clinical Assistant Professor
mesh term: Colorectal Neoplasms
mesh term: Neoplastic Cells, Circulating
sharing ipd: Undecided