<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/NCT03249727</url>
  </required_header>
  <id_info>
    <org_study_id>ANKA-HR</org_study_id>
    <nct_id>NCT03249727</nct_id>
  </id_info>
  <brief_title>Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy</brief_title>
  <acronym>ANKA-HR</acronym>
  <official_title>Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ATGen Canada Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ATGen Canada Inc</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>
      This study will measure the activity of natural killer (NK) cells using the in vitro&#xD;
      diagnostic device NK Vue in high risk subjects (Quebec risk categories P2, P3 and P4)&#xD;
      scheduled for colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Quebec, subjects in risk category P2 are scheduled for colonoscopy due to high suspicion&#xD;
      of cancer based on imaging, sigmoidoscopy or clinical exam. Subjects in categories P3 and P4&#xD;
      are scheduled for colonoscopy for one of the following reasons: suspicion of having an&#xD;
      inflammatory bowel condition, rectal bleeding, presence of occult blood in stool, unexplained&#xD;
      iron deficiency anemia, recent change in bowel habits, family history of CRC or adenomatous&#xD;
      polyps or other hereditary colorectal diseases. Often, colonoscopy is not performed within&#xD;
      the government-prescribed recommended delays, leading to waiting lists for the procedure.&#xD;
      Analysis of NK cell activity may help identify those at risk for the presence of CRC and&#xD;
      therefore help prioritize subjects on these waiting lists, help manage resources and help&#xD;
      convince subjects to have a colonoscopy. Furthermore, all subjects will undergo a FIT,&#xD;
      allowing a determination of the ability of each test alone, as well as a combination of NK&#xD;
      Vue and FIT, to predict outcome on colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruiting issues&#xD;
  </why_stopped>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">October 11, 2018</completion_date>
  <primary_completion_date type="Actual">October 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Endoscopist will not be provided the results of either the FIT or NK Vue tests performed as part of the trial; biochemist will not be provided the results of the colonoscopy</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)</measure>
    <time_frame>NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy</time_frame>
    <description>Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs.</measure>
    <time_frame>FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy</time_frame>
    <description>Test performance of FIT for CRC, using different cut-offs (≥50 ng/mL, ≥ 75 ng/mL, ≥ 100 ng/mL and ≥ 175 ng/mL), will be assessed by calculating the RR and by using ROC analyses at the different cut-offs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test performance of NK Vue in combination with FIT</measure>
    <time_frame>FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling</time_frame>
    <description>Test performance of the combination of FIT at the different cut-offs (≥50 ng/mL, ≥ 75 ng/mL, ≥ 100 ng/mL and ≥ 175 ng/mL) and NK Vue (cut-off of &lt;200 pg/mL), for CRC, will be assessed by calculating the RR and by using ROC analyses. Similar analyses will be done with subjects having either a positive FIT (at different cut-offs) or a NK Vue of &lt;200 pg/mL</description>
  </secondary_outcome>
  <enrollment type="Actual">396</enrollment>
  <condition>Immunity, Innate</condition>
  <condition>Colorectal Cancer</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IVDD for NK cell activity in whole blood</intervention_name>
    <description>Once subject has been scheduled for a colonoscopy by the institution (up to 4 weeks prior to procedure), the subject will perform a FIT at home and an NK Vue test (one sample of one mL of blood) at the institution, prior to the day of colonoscopy.</description>
    <other_name>NK Vue</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects aged 40 and over who are scheduled to undergo colonoscopy at the research&#xD;
             site and who are classified in category P2, P3 or P4.&#xD;
&#xD;
          2. Subjects who provide informed consent to participate in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lack of understanding and/or participation due to illiteracy or inability to&#xD;
             comprehend English or French&#xD;
&#xD;
          2. Subjects in category P3 who are there due to knowledge or suspicion of an inflammatory&#xD;
             bowel disease&#xD;
&#xD;
          3. Previous history of cancer (any type) or active infection (as declared by the subject&#xD;
             at the time of enrolment)&#xD;
&#xD;
          4. Currently participating (or participated within the previous 120 days) in an&#xD;
             investigational therapeutic study (in case of interference of the drug with the immune&#xD;
             system)&#xD;
&#xD;
          5. Subjects who underwent their colonoscopy and&#xD;
&#xD;
               1. the colonoscopy preparation was judged insufficient&#xD;
&#xD;
               2. the colonoscopy itself was judged insufficient or incomplete by the doctor&#xD;
&#xD;
               3. the biopsy sample was lost and cancer could not be pathologically confirmed&#xD;
&#xD;
               4. the colonoscopy detected an inflammatory bowel disease&#xD;
&#xD;
          6. Female who is pregnant, nursing, or of child-bearing potential while not practicing&#xD;
             effective contraceptive methods.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilles Jobin, MD, FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIUSSS de l'Est-de-l'île-de-Montréal; Installation Hôpital Maisonneuve-Rosemont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University and the McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Jobin G, Rodriguez-Suarez R, Betito K. Association Between Natural Killer Cell Activity and Colorectal Cancer in High-Risk Subjects Undergoing Colonoscopy. Gastroenterology. 2017 Oct;153(4):980-987. doi: 10.1053/j.gastro.2017.06.009. Epub 2017 Jun 15.</citation>
    <PMID>28625834</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>natural killer cells</keyword>
  <keyword>natural killer cell activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03249727
org study id: ANKA-HR
nct id: NCT03249727
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will measure the activity of natural killer (NK) cells using the in vitro
      diagnostic device NK Vue in high risk subjects (Quebec risk categories P2, P3 and P4)
      scheduled for colonoscopy.
In Quebec, subjects in risk category P2 are scheduled for colonoscopy due to high suspicion
      of cancer based on imaging, sigmoidoscopy or clinical exam. Subjects in categories P3 and P4
      are scheduled for colonoscopy for one of the following reasons: suspicion of having an
      inflammatory bowel condition, rectal bleeding, presence of occult blood in stool, unexplained
      iron deficiency anemia, recent change in bowel habits, family history of CRC or adenomatous
      polyps or other hereditary colorectal diseases. Often, colonoscopy is not performed within
      the government-prescribed recommended delays, leading to waiting lists for the procedure.
      Analysis of NK cell activity may help identify those at risk for the presence of CRC and
      therefore help prioritize subjects on these waiting lists, help manage resources and help
      convince subjects to have a colonoscopy. Furthermore, all subjects will undergo a FIT,
      allowing a determination of the ability of each test alone, as well as a combination of NK
      Vue and FIT, to predict outcome on colonoscopy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy
primary purpose: Screening
masking: Single (Outcomes Assessor)
masking description: Endoscopist will not be provided the results of either the FIT or NK Vue tests performed as part of the trial; biochemist will not be provided the results of the colonoscopy
measure: Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)
time frame: NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy
description: Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics
measure: Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs.
time frame: FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy
description: Test performance of FIT for CRC, using different cut-offs (≥50 ng/mL, ≥ 75 ng/mL, ≥ 100 ng/mL and ≥ 175 ng/mL), will be assessed by calculating the RR and by using ROC analyses at the different cut-offs.
measure: Test performance of NK Vue in combination with FIT
time frame: FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling
description: Test performance of the combination of FIT at the different cut-offs (≥50 ng/mL, ≥ 75 ng/mL, ≥ 100 ng/mL and ≥ 175 ng/mL) and NK Vue (cut-off of <200 pg/mL), for CRC, will be assessed by calculating the RR and by using ROC analyses. Similar analyses will be done with subjects having either a positive FIT (at different cut-offs) or a NK Vue of <200 pg/mL
intervention type: Diagnostic Test
intervention name: IVDD for NK cell activity in whole blood
description: Once subject has been scheduled for a colonoscopy by the institution (up to 4 weeks prior to procedure), the subject will perform a FIT at home and an NK Vue test (one sample of one mL of blood) at the institution, prior to the day of colonoscopy.
other name: NK Vue
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles Jobin, MD, FRCP
role: Principal Investigator
affiliation: CIUSSS de l'Est-de-l'île-de-Montréal; Installation Hôpital Maisonneuve-Rosemont
facility: 
facility: 
facility: 
country: Canada
citation: Jobin G, Rodriguez-Suarez R, Betito K. Association Between Natural Killer Cell Activity and Colorectal Cancer in High-Risk Subjects Undergoing Colonoscopy. Gastroenterology. 2017 Oct;153(4):980-987. doi: 10.1053/j.gastro.2017.06.009. Epub 2017 Jun 15.
PMID: 28625834
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No