NCT03249727

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: ATGen Canada Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immunity, Innate
• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-05
• Primary completion: 2018-10-11
• Completion: 2018-10-11
• First posted: 2017-08-15
• Last updated: 2023-01-31

Locations

3 sites across 1 country: Canada