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

Primary Purpose

Immunity, Innate, Colorectal Cancer

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

IVDD for NK cell activity in whole blood

About this trial

This is an interventional screening trial for Immunity, Innate focused on measuring natural killer cells, natural killer cell activity

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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
Female who is pregnant, nursing, or of child-bearing potential while not practicing effective contraceptive methods.

Sites / Locations

CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont
Centre Hospitalier de l'Université de Montréal
McGill University and the McGill University Health Centre

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT03249727

First Posted

August 10, 2017

Last Updated

January 30, 2023

Sponsor

ATGen Canada Inc

1. Study Identification

Unique Protocol Identification Number

NCT03249727

Brief Title

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

Acronym

ANKA-HR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Recruiting issues

Study Start Date

July 5, 2017 (Actual)

Primary Completion Date

October 11, 2018 (Actual)

Study Completion Date

October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ATGen Canada Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunity, Innate, Colorectal Cancer

Keywords

natural killer cells, natural killer cell activity

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy

Masking

Outcomes Assessor

Masking Description

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

Allocation

N/A

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Diagnostic Test

Intervention Name(s)

IVDD for NK cell activity in whole blood

Other Intervention Name(s)

NK Vue

Intervention Description

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.

Primary Outcome Measure Information:

Title

Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4)

Description

Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics

Time Frame

NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy

Title

Test performance of NK Vue in combination with FIT

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles Jobin, MD, FRCP

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Centre Hospitalier de l'Université de Montréal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3J4

Country

Canada

Facility Name

McGill University and the McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28625834

Citation

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.

Results Reference

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

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