<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/NCT04417010</url>
  </required_header>
  <id_info>
    <org_study_id>2020-2-2152</org_study_id>
    <nct_id>NCT04417010</nct_id>
  </id_info>
  <brief_title>To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation</brief_title>
  <official_title>A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Cancer Hospital &amp; Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver&#xD;
      metastases with different KRAS gene status&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</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>local tumor progression</measure>
    <time_frame>2020-06-01-2023-05-31</time_frame>
    <description>the appearance of tumor foci at the edge of the ablation zones after at least one contrast-enhanced follow-up study has documented adequate ablation and covered by the ablation zone in the target tumor and surrounding ablation margin using imaging criteria</description>
  </primary_outcome>
  <enrollment type="Anticipated">163</enrollment>
  <condition>KRAS Gene</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Liver Metastasis</condition>
  <condition>Safe Margin</condition>
  <condition>Radiofrequency Ablation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency ablation</intervention_name>
    <description>Both groups of patients underwent radiofrequency ablation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men or women 18 years of age or older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed as liver metastasis of colorectal cancer;&#xD;
&#xD;
          2. There are no more than 3 liver metastases and all the lesions are not more than 5 cm;&#xD;
             or no more than 6 liver metastases and all the lesions are not more than 3.0 cm;&#xD;
&#xD;
          3. The primary lesion of colorectal cancer has been treated curatively or is planned to&#xD;
             undergo curative treatment;&#xD;
&#xD;
          4. KRAS gene test results can be obtained for primary or metastatic foci;&#xD;
&#xD;
          5. Signing informed consent voluntarily;&#xD;
&#xD;
          6. Men or women who have reached the age of 18;&#xD;
&#xD;
          7. Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment;&#xD;
&#xD;
          8. Platelet count&gt; 50,000/mm3, prothrombin activity&gt; 50%;&#xD;
&#xD;
          9. Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and&#xD;
             ascites;&#xD;
&#xD;
         10. Subjects are willing to return to the research center for research follow-up;&#xD;
&#xD;
         11. Life expectancy ≥ 6 months-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. suffer from but not limited to the following serious diseases: congestive heart&#xD;
             failure, myocardial infarction or cerebrovascular accident, or life-threatening&#xD;
             arrhythmia in the past 6 months;&#xD;
&#xD;
          2. During pregnancy or lactation. Before receiving research treatment, women of&#xD;
             childbearing age must have a negative serum pregnancy test;&#xD;
&#xD;
          3. Any known allergic reactions to the intravenous imaging agent used in this study;&#xD;
&#xD;
          4. There is portal vein or hepatic vein tumor infiltration/carcinoma;&#xD;
&#xD;
          5. International normalized ratio of prothrombin&gt; 1.5 times the upper limit of normal&#xD;
             value (UNL) of the research center;&#xD;
&#xD;
          6. Platelet count &lt;50,000/mm3, absolute neutrophil count &lt;1500/mm3, or heme value&#xD;
             &lt;10.0g/dL;&#xD;
&#xD;
          7. Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min;&#xD;
&#xD;
          8. Serum bilirubin&gt;3.0mg/dL;&#xD;
&#xD;
          9. Serum albumin &lt;2.8g/dL;&#xD;
&#xD;
         10. Body temperature &gt;101°F (38.3°C) immediately before study treatment;&#xD;
&#xD;
         11. being treated with other research drugs;&#xD;
&#xD;
         12. Heart failure NYHA function grade is III or IV .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Kun Yan</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Liver 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/NCT04417010
org study id: 2020-2-2152
nct id: NCT04417010
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver
      metastases with different KRAS gene status
observational model: Cohort
time perspective: Prospective
measure: local tumor progression
time frame: 2020-06-01-2023-05-31
description: the appearance of tumor foci at the edge of the ablation zones after at least one contrast-enhanced follow-up study has documented adequate ablation and covered by the ablation zone in the target tumor and surrounding ablation margin using imaging criteria
intervention type: Procedure
intervention name: Radiofrequency ablation
description: Both groups of patients underwent radiofrequency ablation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Kun Yan
investigator title: director
mesh term: Neoplasm Metastasis
mesh term: Liver Neoplasms
sharing ipd: Undecided