Human Blood Specimen Collection to Evaluate Immune Cell Function

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Surgery; Perioperative Care
• Intervention / Treatment: Other: Natural Killer Cell Activity Assay

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Inability or unwillingness to sign informed consent form
• History of active viral or bacterial infection
• History of prescription use of immunosuppressive drugs within the last six months
• History of anticancer treatments including radiation or chemotherapy
• History of autoimmune disorders (rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease including Crohn's disease, Type I diabetes, Guillain-Barré syndrome)
• Known HIV, Hepatitis B, or Hepatitis C infection

Description

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:

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Natural Killer Cell Activity Assay; Subjects had a blood test to measure NK cell activity (NKA) at different time points; Other Names: NK-Vue
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.	Other: Natural Killer Cell Activity Assay; Subjects had a blood test to measure NK cell activity (NKA) at different time points; Other Names: NK-Vue

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: ATGen Canada Inc
• Investigators: Principal Investigator: Rebecca C Auer, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Perioperative/Postoperative Complications; Immune Suppression; Natural Killer Cell Mediated Immunity; Natural Killer Cell Cytokine Production
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20160012-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No