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Human Blood Specimen Collection to Evaluate Immune Cell Function

Human Blood Specimen Collection to Evaluate Immune Cell Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03422120
Enrollment
69
Registered
2018-02-05
Start date
2016-08-01
Completion date
2018-10-01
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Perioperative Care, Surgery

Keywords

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

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.

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.

Interventions

OTHERNatural Killer Cell Activity Assay

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

Sponsors

ATGen Canada Inc
CollaboratorINDUSTRY
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patientsbaseline vs. Postoeprative Day (POD) 1Measure of NK cell IFN-gamma secretion

Secondary

MeasureTime frameDescription
Natural Killer Cell Activity (NKA) in healthy donors (HD) as compared to colorectal cancer (CRC) patients (at baseline)baselineMeasure of NK cell IFN-gamma secretion

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026