Human Blood Specimen Collection to Evaluate Immune Cell Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NK Cells Infusion for Advanced Malignancies

NCT03619954

Immunotherapy

UNKNOWN PHASE1

Blood Sampling of Healthy Volunteers for Immunological Research

NCT03819829

Healthy Volunteers

RECRUITING NA

The Role of NK Cells to Detect Blood Infection in ALL.

NCT06160115

Acute Lymphoblastic Leukemia Bloodstream Infection

NOT_YET_RECRUITING

Clinical Efficacy and Safety of NKT Cell Infusion in Patients With Advanced Solid Tumor

NCT02562963

Non-small Cell Lung Cancer Gastric Cancer Hepatocellular Carcinoma +1 more

UNKNOWN PHASE1/PHASE2

The Change of NK Cell Activity After Head and Neck Cancer Surgery

NCT02661776

The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Surgery Perioperative Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Natural Killer Cell Activity Assay

Intervention Type OTHER

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

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.

Natural Killer Cell Activity Assay

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Natural Killer Cell Activity Assay

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NK-Vue

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes