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

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ClinicalTrials.gov Identifier: NCT03249727
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
ATGen Canada Inc

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.

Condition or disease Intervention/treatment Phase
Immunity, Innate Colorectal Cancer Diagnostic Test: IVDD for NK cell activity in whole blood Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will have a FIT (OC FIT-CHEK, Polymedco) and NK Vue test prior to colonoscopy
Masking: Single (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
Primary Purpose: Screening
Official Title: Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy


Intervention Details:
  • Diagnostic Test: IVDD for NK cell activity in whole blood
    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.
    Other Name: NK Vue


Primary Outcome Measures :
  1. 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 ]
    Test performance of NK Vue for CRC will be assessed by ROC analysis and logistic regression, adjusting for subject baseline characteristics


Secondary Outcome Measures :
  1. Test performance of FIT, to be determined at different cut-offs reflective of the various Canadian provincial cut-offs. [ Time Frame: FIT performed at home and sample brought to institution within 7 days of collection and prior to coloscopy ]
    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.

  2. Test performance of NK Vue in combination with FIT [ Time Frame: FIT and NK Vue performed up to 4 weeks prior to colonoscopy, with NK Vue draw within 7 days of stool sampling ]
    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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249727


Contacts
Contact: Isabelle Bouchard 514-252-3400 ext 4250 ibouchard.hmr@ssss.gouv.qc.ca

Locations
Canada, Quebec
CIUSSS de l'Est-de-l'île-de-Montréal, Installation Hôpital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Isabelle Bouchard    514-252-3400 ext 4250    ibouchard.hmr@ssss.gouv.qc.ca   
Principal Investigator: Gilles Jobin, MD,FRCP,MSc         
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X 3J4
Contact: Nancy Nadeau    514-890-8000 ext 30919    nancy.nadeau.chum@ssss.gouv.qc.ca   
Contact: Alexia Monges, MSc    514-890-8000 ext 30655    alexia.monges.chum@ssss.gouv.qc.ca   
Principal Investigator: Michel Boivin, MD,FRCPC,MM         
McGill University and the McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Myriam Martel, MSc    514-934-8233    myriam_martel@yahoo.ca   
Principal Investigator: Alan Barkun, MD,CM,MSc         
Sponsors and Collaborators
ATGen Canada Inc
Investigators
Principal Investigator: Gilles Jobin, MD, FRCP CIUSSS de l'Est-de-l'île-de-Montréal; Installation Hôpital Maisonneuve-Rosemont

Publications:
Responsible Party: ATGen Canada Inc
ClinicalTrials.gov Identifier: NCT03249727     History of Changes
Other Study ID Numbers: ANKA-HR
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ATGen Canada Inc:
natural killer cells
natural killer cell activity

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases