NCT03249727

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

August 10, 2017

Last Update Submit

January 30, 2023

Conditions

Immunity, InnateColorectal Cancer

Keywords

natural killer cellsnatural killer cell activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial 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

    FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling

Interventions

IVDD for NK cell activity in whole bloodDIAGNOSTIC_TEST

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.

Also known as: NK Vue

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Subjects who provide informed consent to participate in the trial

You may not qualify if:

  • Lack of understanding and/or participation due to illiteracy or inability to comprehend English or French
  • Subjects in category P3 who are there due to knowledge or suspicion of an inflammatory bowel disease
  • Previous history of cancer (any type) or active infection (as declared by the subject at the time of enrolment)
  • 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)
  • Subjects who underwent their colonoscopy and
  • the colonoscopy preparation was judged insufficient
  • the colonoscopy itself was judged insufficient or incomplete by the doctor
  • the biopsy sample was lost and cancer could not be pathologically confirmed
  • the colonoscopy detected an inflammatory bowel disease
  • Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3J4, Canada

Location

McGill University and the McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28625834BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Gilles Jobin, MD, FRCP

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Endoscopist will not be provided the results of either the FIT or NK Vue tests performed as part of the trial; biochemist will not be provided the results of the colonoscopy
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

July 5, 2017

Primary Completion

October 11, 2018

Study Completion

October 11, 2018

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)