Human Blood Specimen Collection to Evaluate Immune Cell Function

January 14, 2019 updated by: Ottawa Hospital Research Institute
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: baseline vs. Postoeprative Day (POD) 1
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)
Time Frame: baseline
Measure of NK cell IFN-gamma secretion
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

ATGen Canada Inc

Investigators

  • Principal Investigator: Rebecca C Auer, MD, Ottawa Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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