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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Immunity, Innate
• Intervention / Treatment: Diagnostic test: IVDD for NK cell activity in whole blood

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.

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'Est-de-l'Île-de-Montréal, Installation Hopital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H2X 3J4
      • Centre Hospitalier de l'Université de Montréal
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University and the McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling

Collaborators and Investigators

• Sponsor: ATGen Canada Inc
• Investigators: Principal Investigator: Gilles Jobin, MD, FRCP, CIUSSS de l'Est-de-l'île-de-Montréal; Installation Hôpital Maisonneuve-Rosemont

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Actual): October 11, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: natural killer cells; natural killer cell activity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ANKA-HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No