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| Name | Class |
|---|---|
| ATGen Canada Inc | INDUSTRY |
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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-É£ (IFN-É£) based assay (NK-Vueâ„¢) in healthy humans and colorectal cancer (CRC) surgery patients seen a The Ottawa Hospital. The results of this study will determine if the NK-Vueâ„¢ 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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Donors | Healthy patients, without a diagnosis of cancer and age>40. The Natural Killer Cell Activity Assay (NKA) will be measured with a blood test. |
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| Colorectal Cancer Surgery Patients | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Killer Cell Activity Assay | Other | Subjects had a blood test to measure NK cell activity (NKA) at different time points |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca C Auer, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Patient and healthy donor blood was drawn at indicated time points into BD Vacutainer Sodium Heparin coated tubes (~30mL/blood draw) and processed within 4 hrs. 1 mL of whole blood was aliquoted into vacutainer tubes containing PromocoaTM and from the remaining whole blood sample peripheral blood mononuclear cells (PBMCs) were isolated by Ficoll density centrifugation prior to cryopreservation in freezing media (10% DMSO and 90% FBS).
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |