Human Blood Specimen Collection to Evaluate Immune Cell Function

NCT03422120 | Completed

• 1 other identifier: 20160012-01H
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Surgery; Perioperative Care

Keywords

Immune Suppression; Natural Killer Cell Mediated Immunity; Natural Killer Cell Cytokine Production; Perioperative/Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Natural Killer Cell Activity (NKA) in healthy donors (HD) as compared to colorectal cancer (CRC) patients (at baseline)

  baseline

Study Arms (2)

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

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

Interventions

Natural Killer Cell Activity Assay OTHER

Subjects had a blood test to measure NK cell activity (NKA) at different time points

Also known as: NK-Vue

Colorectal Cancer Surgery Patients; Healthy Donors

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• ATGen Canada Inc: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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).

MeSH Terms

Conditions

Colorectal Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca C Auer, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 5, 2018
• Study Start: August 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2018-01

Locations

CA (1)