Human Blood Specimen Collection to Evaluate Immune Cell Function

Study Overview
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Brief Summary
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Natural killer (NK) cells are leukocytes of the innate immune system and play a central role in the control of cancer metastases. NK cells and other innate immune cells often do not function well in patients with cancer and are also profoundly suppressed after cancer surgery. Dr. Auer's Lab and others have shown that NK cells are critically important in the clearance of tumor metastases and that their impairment can be recovered with immune therapy augmenting the innate immune system. Several studies suggest that cancer patients have depressed NK cell cytotoxicity as compared to healthy controls but that following resection of the cancer, NK cell cytotoxicity returns to normal levels. In this observational study, the investigators will measure NK cell cytotoxicity by the gold standard method (51Cr, a chromium51 release assay) and by a new interferon-ɣ (IFN-ɣ) based assay (NK-Vue™) in healthy humans and colorectal cancer (CRC) surgery patients seen a The Ottawa Hospital. The results of this study will determine if the NK-Vue™ is able to discriminate between healthy human volunteers and newly diagnosed cancer patients and is sufficiently sensitive to detect transient NK cell suppression immediately following surgery.

Detailed Description
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Rationale: The purpose of this program is to obtain consent for and to outline the process for collection of fresh blood sample from healthy humans and colorectal cancer patients before and after surgical resection. Procurement of fresh human blood is required for the following: To compare NK cell function, measured by two different assays, in healthy humans and newly diagnosed colorectal cancer patients at the Ottawa Hospital. To compare NK cell function, measure by two different assays in colorectal surgery patients preoperatively and at various time points postoperatively.

Official Title
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Human Blood Specimen Collection to Evaluate Immune Cell Function

Conditions
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Perioperative Care, Colorectal Cancer, Surgery

Intervention / Treatment
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* Other: Natural Killer Cell Activity Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have had a recent diagnosis of cancer (any stage) and will be undergoing surgery (cancer group) Subjects who are being seen by their physician for other reasons, or healthy volunteers (control group) Subjects who provide informed consent to participate in the trial Subjects >40 years of age Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Donors<br>Healthy patients, without a diagnosis of cancer and age>40. The Natural Killer Cell Activity Assay (NKA) will be measured with a blood test. | Other: Natural Killer Cell Activity Assay<br>* Subjects had a blood test to measure NK cell activity (NKA) at different time points<br>* Other names: NK-Vue;|
| Colorectal Cancer Surgery Patients<br>Patients >40 years of age with a histologically confirmed diagnosis of primary colorectal cancer and a planned surgical resection of the primary tumour. The Natural Killer Cell Activity Assay (NKA) will be measured at various perioperative time points with a blood test. | Other: Natural Killer Cell Activity Assay<br>* Subjects had a blood test to measure NK cell activity (NKA) at different time points<br>* Other names: NK-Vue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patients | Measure of NK cell IFN-gamma secretion | baseline vs. Postoeprative Day (POD) 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural Killer Cell Activity (NKA) in healthy donors (HD) as compared to colorectal cancer (CRC) patients (at baseline) | Measure of NK cell IFN-gamma secretion | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune Suppression, Natural Killer Cell Mediated Immunity, Natural Killer Cell Cytokine Production, Perioperative/Postoperative Complications