Human Blood Specimen Collection to Evaluate Immune Cell Function

Colorectal Cancer Clinical Trial

Official title:

Human Blood Specimen Collection to Evaluate Immune Cell Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422120
• Other study ID #: 20160012-01H
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Perioperative Care
• Surgery

Intervention

Other:
• Natural Killer Cell Activity Assay
Subjects had a blood test to measure NK cell activity (NKA) at different time points

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	ATGen Canada Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patients	Measure of NK cell IFN-gamma secretion	baseline vs. Postoeprative Day (POD) 1
Secondary	Natural Killer Cell Activity (NKA) in healthy donors (HD) as compared to colorectal cancer (CRC) patients (at baseline)	Measure of NK cell IFN-gamma secretion	baseline