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OpenTrials
Completed

NCT Number: NCT03422120

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Natural Killer Cell Activity Assay

Other

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

Other names: NK-Vue

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • ATGen Canada Inc

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2018
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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