Colorectal CancerNCT03422120
Human Blood Specimen Collection to Evaluate Immune Cell Function
An observational study of Colorectal Cancer and Surgery, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Surgery, Perioperative Care
- What is being tested?
- Natural Killer Cell Activity Assay
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2016to 1 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer, Surgery, Perioperative Care
- Being tested
- Natural Killer Cell Activity Assay
- Keywords
- Immune Suppression, Natural Killer Cell Mediated Immunity, Natural Killer Cell Cytokine Production, Perioperative/Postoperative Complications
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Killer Cell Activity AssayOther
Also called NK-Vue
Subjects had a blood test to measure NK cell activity (NKA) at different time points
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Natural Killer Cell Activity Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patients
Measure of NK cell IFN-gamma secretion
Measured: baseline vs. Postoeprative Day (POD) 1
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Aug 2016
- Primary completion1 Mar 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- ATGen Canada Inc
- Responsible party
- Sponsor
- Investigators
- Rebecca C Auer, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422120
- Sponsor's protocol ID
- 20160012-01H
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Blood Specimen Collection to Evaluate Immune Cell Function
- ClinicalTrials.gov ID
- NCT03422120
- Acronym / sponsor ID
- 20160012-01H
- Conditions
- Colorectal Cancer, Surgery, Perioperative Care
- Keywords
- Immune Suppression, Natural Killer Cell Mediated Immunity, Natural Killer Cell Cytokine Production, Perioperative/Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- ATGen Canada Inc
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Donors | – | Other: Natural Killer Cell Activity AssayHealthy patients, without a diagnosis of cancer and age>40. The Natural Killer Cell Activity Assay (NKA) will be measured with a blood test. |
| Colorectal Cancer Surgery Patients | – | Other: Natural Killer Cell Activity AssayPatients >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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural Killer Cell Activity AssayAlso: NK-VueSubjects had a blood test to measure NK cell activity (NKA) at different time points | Other | Colorectal Cancer Surgery Patients, Healthy Donors |
Primary outcome
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
1 secondary outcome
Natural Killer Cell Activity (NKA) in healthy donors (HD) as compared to colorectal cancer (CRC) patients (at baseline)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca C Auer, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Surgery, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural Killer Cell Activity (NKA) at baseline compared to POD1 in CRC surgery patients (time frame: baseline vs. Postoeprative Day (POD) 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.