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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
SINGLE
Enrollment
396
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.
CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
McGill University and the McGill University Health Centre
Montreal, Quebec, Canada
Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)
Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics
Time frame: NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy
Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs.
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.
Time frame: FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy
Test performance of NK Vue in combination with FIT
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
Time frame: FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.