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Immunity, InnateANKA-HRNCT03249727

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

A study testing IVDD for NK cell activity in whole blood in people with Immunity, Innate and Colorectal Cancer, run by ATGen Canada Inc at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Immunity, Innate, Colorectal Cancer
What is being tested?
IVDD for NK cell activity in whole blood
How many people
396 participants
Where
3 sitesCanada
Study dates
5 Jul 2017to 11 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

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

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3J4

  • McGill University and the McGill University Health Centre

    Montreal, Quebec, H3G 1A4

Other trials in Canada

About this study

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.

Read the 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.

Being tested
IVDD for NK cell activity in whole blood
Keywords
natural killer cells, natural killer cell activity
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVDD for NK cell activity in whole bloodDiagnostic test

    Also called NK Vue

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)

  1. 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.

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

  2. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start5 Jul 2017
  3. Primary completion11 Oct 2018
  4. Study completion11 Oct 2018

Why it stopped: Recruiting issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249727
Sponsor's protocol ID
ANKA-HR
Acronym
ANKA-HR
Status last verified
Jan 2023
First submitted
10 Aug 2017
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28625834

Questions about this trial

What is this clinical trial studying?

A study testing IVDD for NK cell activity in whole blood in people with Immunity, Innate and Colorectal Cancer, run by ATGen Canada Inc at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruiting issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test performance of NK Vue (ability of NK Vue to detect CRC in those subjects in risk categories P2, P3 or P4) (time frame: NK Vue blood draw taken within 7 days of FIT stool sampling and prior to colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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