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

ATGen

Status: Terminated

Conditions: Immunity, Innate; Colorectal Cancer

Treatments: Diagnostic Test: IVDD for NK cell activity in whole blood

Study type: Interventional

Funder types: Industry

Identifiers

NCT03249727

ANKA-HR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind