Clinical trial NCT03249727: Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
Official title: Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Immunity, Innate
Colorectal Cancer
Keywords: natural killer cells
natural killer cell activity
Lead sponsor: ATGen Canada Inc
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 396
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)
timeFrame: NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy
Secondary outcomes:
measure: Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs.
timeFrame: FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy
measure: Test performance of NK Vue in combination with FIT
timeFrame: FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: McGill University and the McGill University Health Centre
state: Quebec
Study officials:
affiliation: CIUSSS de l'Est-de-l'île-de-Montréal; Installation Hôpital Maisonneuve-Rosemont
name: Gilles Jobin, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.