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Trial record 34 of 318 for:    colon cancer | ( Map: Canada )

Human Blood Specimen Collection to Evaluate Immune Cell Function

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ClinicalTrials.gov Identifier: NCT03422120
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
ATGen Canada Inc
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment
Colorectal Cancer Surgery Perioperative Care Other: Natural Killer Cell Activity Assay

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.

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Blood Specimen Collection to Evaluate Immune Cell Function
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: NK-Vue




Primary Outcome Measures :
  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 Outcome Measures :
  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


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).


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422120


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
ATGen Canada Inc
Investigators
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Principal Investigator: Rebecca C Auer, MD Ottawa Hospital Research Institute

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03422120     History of Changes
Other Study ID Numbers: 20160012-01H
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Immune Suppression
Natural Killer Cell Mediated Immunity
Natural Killer Cell Cytokine Production
Perioperative/Postoperative Complications
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases