Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Oculocerebral Syndrome With Hypopigmentation

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Two samples of one mL of blood (for baseline IFN-gamma activity and for NK cell activity) and blood samples collected for C-Reactive Protein and White Blood Cell Count, taken up to 8 weeks prior to biopsy and before treatment with antibiotics.

IVDD for NK cell activity in whole blood

Neil E Fleshner, MPH,MD,FRCSC

This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate biopsy.

The NK Vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon-gamma using an immunoassay. NK Vue is intended to be used for the monitoring of the immune status of individuals. Measurement of NK cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be affected.

NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab

Self-representation (must have a prostate gland)

Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

Open Label, Prospective, Cross-Sectional Clinical Performance Study of the in Vitro Diagnostic Device NK VueTM: Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

Test performance of NK Vue will be assessed by logistic regression, both unadjusted and adjusted for the effects of at least PSA, age, digital rectal examination, and family history

Test performance of NK Vue will be assessed by multinomial logistic regression, using the following known predictors of prostate cancer: age, ethnicity, PSA history, family history of prostate cancer, prostate volume, digital rectal examination findings, and number of prior biopsies.

The sensitivity, specificity, positive and negative predictive values for the detection of prostate cancer, will be calculated using Receiver Operating Characteristics analysis (at a cut-off of 4 ng/mL for PSA and at a cut-off of 200 pg/mL for NK Vue). Other cut-offs may be used to perform additional statistical analyses for test performance.

The sensitivity, specificity, positive and negative predictive values for the detection of prostate cancer, will be calculated using Receiver Operating Characteristics analysis under combined conditions.

ATGen Canada Inc

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

Gilles Jobin, MD, FRCP

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.

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.

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

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

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

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

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 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy	NCT03242265	Immunity, Innat... Prostatic Neopl...	IVDD for NK cel...	18 Years -	ATGen Canada Inc
Analysis of Natural Killer Cell Activity (NKA) in Whole Blood in High Risk Subjects Undergoing Colonoscopy	NCT03249727	Immunity, Innat... Colorectal Canc...	IVDD for NK cel...	40 Years -	ATGen Canada Inc

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