<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/NCT03289988</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0148</org_study_id>
    <nct_id>NCT03289988</nct_id>
  </id_info>
  <brief_title>Novel Blood-based Colorectal Cancer Screening Method Using Natural Killer Cell Activity and Gene Panel Expression</brief_title>
  <official_title>Novel Blood-based Colorectal Cancer Screening Method Using Natural Killer Cell Activity and Gene Panel Expression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</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>
      Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the&#xD;
      innate immune system. In particular, it plays a very important defense function against host&#xD;
      cells or cancer cells infected with a specific virus. Recent studies have shown that the&#xD;
      activity of NK cells is decreased in patients with various carcinomas compared with normal&#xD;
      controls, suggesting that the measurement of activity of NK cells in the blood may be helpful&#xD;
      in the early diagnosis of cancer. In a recent study analyzing NK cell activity in 762&#xD;
      patients undergoing colonoscopy, NK cell activity showed performance in diagnosing advanced&#xD;
      colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity&#xD;
      58.3% and 59.5%, respectively. This finding suggests that NK cell activity may be useful as a&#xD;
      screening method for colorectal neoplasms. However, as a single test, this diagnostic power&#xD;
      is relatively low. On the other hands, another blood-based colorectal cancer screening test&#xD;
      that using 29 gene panels algorithm has recently been reported. According to this study, 29&#xD;
      gene panel algorithms (Colox®) showed performance in diagnosing advanced colorectal adenoma&#xD;
      and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%,&#xD;
      respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. Although&#xD;
      the Colox® test seems to be useful for the colorectal cancer screening using blood test, this&#xD;
      diagnostic power is relatively low. In order to overcome low diagnostic performance of&#xD;
      aforementioned tests (NK activity and Colox®) as a single use, combination of individual&#xD;
      biomarkers can be a promising alternative. In this regards, the aim of this study was to&#xD;
      evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining&#xD;
      Colox® and NK cell activity indicators.&#xD;
    </textblock>
  </brief_summary>
  <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">August 2019</completion_date>
  <primary_completion_date type="Anticipated">June 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Power for prediction of advanced colorectal neoplasms</measure>
    <time_frame>2 months</time_frame>
    <description>Diagnostic Power for prediction of advanced colorectal neoplasms using combination of conventional Colox® and NK Cell Activity Indicators.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">964</enrollment>
  <condition>Colorectal Adenoma</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Normal group</arm_group_label>
    <description>Normal group(control group): patients with negative colonoscopy findings (n= 238).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low risk adenoma group</arm_group_label>
    <description>Low risk adenoma group: patients having at least one low risk adenoma (n=250).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk adenoma group</arm_group_label>
    <description>High-risk adenoma group: patients having at least one of following criteria (more than 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia findings) (n=316).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colon cancer</arm_group_label>
    <description>Colon cancer: histologically confirmed colon cancer patients (n=160).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sampling</intervention_name>
    <description>NK activity and gene panel expression analysis based on blood test (5cc blood sampling)</description>
    <arm_group_label>Colon cancer</arm_group_label>
    <arm_group_label>High-risk adenoma group</arm_group_label>
    <arm_group_label>Low risk adenoma group</arm_group_label>
    <arm_group_label>Normal group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood sampling for genetic analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. Normal group: patients with negative colonoscopy findings (n= 238).&#xD;
&#xD;
          2. Low risk adenoma group: patients having at least one low risk adenoma (n=250).&#xD;
&#xD;
          3. High-risk adenoma group: patients having at least one of following criteria (more&#xD;
             thatn 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia&#xD;
             findings) (n=316).&#xD;
&#xD;
          4. Colon cancer: histologically confirmed colon cancer patients (n=160).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults population over 40 years of age&#xD;
&#xD;
          -  Patients who understood this study process and agreed to participation of this study&#xD;
&#xD;
          -  Colon cancer patients who have been confirmed as colorectal cancer by endoscopic&#xD;
             biopsy within 1 month&#xD;
&#xD;
          -  Colon cancer patients who received no anticancer treatment such as surgery,&#xD;
             chemotherapy, radiation therapy after cancer diagnosis.&#xD;
&#xD;
          -  Colorectal adenoma and normal control group: Patients undergoing colonoscopy for&#xD;
             diagnostic purposes or colorectal cancer screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who did not agree to participate in the study and did not write their&#xD;
             informed consent&#xD;
&#xD;
          -  Vulnerable subjects with mental retardation or severe psychiatric illness.&#xD;
&#xD;
          -  Patients who are not appropriate enrollment of this study by researchers judgement.&#xD;
&#xD;
          -  Patients who have had an immunosuppressive drug within 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Internal Medicine, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>TAE IL KIM, MD</last_name>
      <phone>82-2-2228-1965</phone>
      <email>taeilkim@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</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>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenoma</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/NCT03289988
org study id: 4-2017-0148
nct id: NCT03289988
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the
      innate immune system. In particular, it plays a very important defense function against host
      cells or cancer cells infected with a specific virus. Recent studies have shown that the
      activity of NK cells is decreased in patients with various carcinomas compared with normal
      controls, suggesting that the measurement of activity of NK cells in the blood may be helpful
      in the early diagnosis of cancer. In a recent study analyzing NK cell activity in 762
      patients undergoing colonoscopy, NK cell activity showed performance in diagnosing advanced
      colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity
      58.3% and 59.5%, respectively. This finding suggests that NK cell activity may be useful as a
      screening method for colorectal neoplasms. However, as a single test, this diagnostic power
      is relatively low. On the other hands, another blood-based colorectal cancer screening test
      that using 29 gene panels algorithm has recently been reported. According to this study, 29
      gene panel algorithms (Colox®) showed performance in diagnosing advanced colorectal adenoma
      and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%,
      respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. Although
      the Colox® test seems to be useful for the colorectal cancer screening using blood test, this
      diagnostic power is relatively low. In order to overcome low diagnostic performance of
      aforementioned tests (NK activity and Colox®) as a single use, combination of individual
      biomarkers can be a promising alternative. In this regards, the aim of this study was to
      evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining
      Colox® and NK cell activity indicators.
observational model: Cohort
time perspective: Cross-Sectional
measure: Diagnostic Power for prediction of advanced colorectal neoplasms
time frame: 2 months
description: Diagnostic Power for prediction of advanced colorectal neoplasms using combination of conventional Colox® and NK Cell Activity Indicators.
arm group label: Normal group
description: Normal group(control group): patients with negative colonoscopy findings (n= 238).
arm group label: Low risk adenoma group
description: Low risk adenoma group: patients having at least one low risk adenoma (n=250).
arm group label: High-risk adenoma group
description: High-risk adenoma group: patients having at least one of following criteria (more than 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia findings) (n=316).
arm group label: Colon cancer
description: Colon cancer: histologically confirmed colon cancer patients (n=160).
intervention type: Other
intervention name: blood sampling
description: NK activity and gene panel expression analysis based on blood test (5cc blood sampling)
arm group label: Colon cancer
arm group label: High-risk adenoma group
arm group label: Low risk adenoma group
arm group label: Normal group
Blood sampling for genetic analysis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Adenoma