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

Last updated: January 30, 2023
Sponsor: ATGen Canada Inc
Overall Status: Terminated

Phase

N/A

Condition

Colon Cancer

Colon Cancer; Rectal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT03249727
ANKA-HR
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Lack of understanding and/or participation due to illiteracy or inability tocomprehend English or French
  2. Subjects in category P3 who are there due to knowledge or suspicion of an inflammatorybowel disease
  3. Previous history of cancer (any type) or active infection (as declared by the subjectat the time of enrolment)
  4. Currently participating (or participated within the previous 120 days) in aninvestigational therapeutic study (in case of interference of the drug with the immunesystem)
  5. Subjects who underwent their colonoscopy and
  6. the colonoscopy preparation was judged insufficient
  7. the colonoscopy itself was judged insufficient or incomplete by the doctor
  8. the biopsy sample was lost and cancer could not be pathologically confirmed
  9. the colonoscopy detected an inflammatory bowel disease
  10. Female who is pregnant, nursing, or of child-bearing potential while not practicingeffective contraceptive methods.

Study Design

Total Participants: 396
Study Start date:
July 05, 2017
Estimated Completion Date:
October 11, 2018

Study 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.

Connect with a study center

  • CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec H2X 3J4
    Canada

    Site Not Available

  • McGill University and the McGill University Health Centre

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.