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Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy (ANKA-HR)

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ClinicalTrials.gov Identifier: NCT03249727
Recruitment Status : Terminated (Lack of funding)
First Posted : August 15, 2017
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
ATGen Canada Inc

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE July 5, 2017
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
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 ]
Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P3 or P4) [ Time Frame: NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy ]
Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • 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 ]
    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.
  • 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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • 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 ]
    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.
  • Test performance of NK Vue in combination with FIT [ Time Frame: FIT and NK Vue performed 2-4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
Official Title  ICMJE Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
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
Primary Purpose: Screening
Condition  ICMJE
  • Immunity, Innate
  • Colorectal Cancer
Intervention  ICMJE Diagnostic Test: IVDD for NK cell activity in whole blood
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
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
396
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
1200
Actual Study Completion Date  ICMJE October 11, 2018
Actual Primary Completion Date October 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects aged 40 and over who are scheduled to undergo colonoscopy at the research site and who are classified in category P2, P3 or P4.
  2. Subjects who provide informed consent to participate in the trial

Exclusion Criteria:

  1. Lack of understanding and/or participation due to illiteracy or inability to comprehend English or French
  2. Subjects in category P3 who are there due to knowledge or suspicion of an inflammatory bowel disease
  3. Previous history of cancer (any type) or active infection (as declared by the subject at the time of enrolment)
  4. Currently participating (or participated within the previous 120 days) in an investigational therapeutic study (in case of interference of the drug with the immune system)
  5. Subjects who underwent their colonoscopy and

    1. the colonoscopy preparation was judged insufficient
    2. the colonoscopy itself was judged insufficient or incomplete by the doctor
    3. the biopsy sample was lost and cancer could not be pathologically confirmed
    4. the colonoscopy detected an inflammatory bowel disease
  6. Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249727
Other Study ID Numbers  ICMJE ANKA-HR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ATGen Canada Inc
Study Sponsor  ICMJE ATGen Canada Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gilles Jobin, MD, FRCP CIUSSS de l'Est-de-l'île-de-Montréal; Installation Hôpital Maisonneuve-Rosemont
PRS Account ATGen Canada Inc
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP