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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

Tracking Information
First Submitted Date January 17, 2018
First Posted Date February 5, 2018
Last Update Posted Date January 15, 2019
Actual Study Start Date August 1, 2016
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03422120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 30, 2018)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Human Blood Specimen Collection to Evaluate Immune Cell Function
Official Title Human Blood Specimen Collection to Evaluate Immune Cell Function
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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).
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
Condition
  • Colorectal Cancer
  • Surgery
  • Perioperative Care
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: Other: Natural Killer Cell Activity Assay
  • 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.
    Intervention: Other: Natural Killer Cell Activity Assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 14, 2019)
69
Original Estimated Enrollment
 (submitted: January 30, 2018)
90
Actual Study Completion Date October 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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:

Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03422120
Other Study ID Numbers 20160012-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor Ottawa Hospital Research Institute
Collaborators ATGen Canada Inc
Investigators
Principal Investigator: Rebecca C Auer, MD Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date January 2018