Abdominal CancerNCT06925906
Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen
An observational study of Abdominal Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The Auer Lab research program studies how surgery affects the immune system and how this can lead to suppression in cancer patients which can lead to cancer reoccurrence. This has been well characterized in literature, with a clear demonstration that both surgery induced suppression of T cell and Natural Killer (NK)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Abdominal Cancer
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2023to 18 Aug 2024
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ottawa Hospital Cancer patients undergoing abdominal surgeries
Who may be able to join
- Patients with a diagnosis of a primary abdominal malignancy consented to undergo major surgery with a planned length of stay of 3 or more days.
- Eligible patients must have signed a consent for surgical resection of the malignancy.
- Adequate hematological function defined as: platelet count ≥ 100 x 109/L, absolute neutrophil count ≥ 1 x 109/L, white blood count ≥ 2.5 x 109/L, hemoglobin count ≥ 90 g/L.
- Adequate organ functioning, including: total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST, ALT < 2.5 x ULN; INR <1.5 ; CrCl>30mL/min.
- Ability to understand and provide a signed informed consent form (ICF) approved by the Institutional Review Board (IRB/IEC/REB).
- Ability to comply with protocol requirements.
Who cannot join
- Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (<7.5 mg daily).
- History of autoimmune disease (even if controlled with medication) such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
- Allergies or any contraindication to the use of tadalafil or any components of Cialis® or the influenza vaccine (including eggs), Agriflu®.
- Serious intercurrent chronic or acute illness, or other illness considered by the investigator as an unwarranted high risk for an investigational product.
- Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
- Patients with resting hypotension (BP <90/50 at rest) or hypertension (BP >170/110 at rest).
- Patients with cardiac failure or coronary artery disease causing unstable angina.
Trial locations and contacts
1 site in 1 country.
About this study
The Auer Lab research program studies how surgery affects the immune system and how this can lead to suppression in cancer patients which can lead to cancer reoccurrence. This has been well characterized in literature, with a clear demonstration that both surgery induced suppression of T cell and Natural Killer (NK) cell result in cancer recurrence..
The present study is the first in humans, to our knowledge, to demonstrate antigen specific dysfunction in T cells and B cells following cancer surgery. The study capitalized on the widespread vaccination of cancer patients against COVID before surgery, which allowed us to measure the response to the antigen S protein of SARS-CoV2. While the study is translational in methodology, we believe it will be of significant interest to all surgeons because it clearly establishes that surgery profoundly suppresses antigen-specific T and B cell responses, which have implications for postoperative infectious complications and cancer recurrence for those patients undergoing tumor resection
- Conditions
- Abdominal Cancer
- Keywords
- Suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with Abdominal cancers | Cancer patients who have been vaccinated with 2 or more doses of the Pfizer BNT162b1 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the degree and determine the postoperative time course of antigen-specific T cell dysfunction following surgery
Used the production of IFNγ, as measured by ELISpot, to determine the degree and duration of surgery-induced suppression of T cell responses to the RBD antigen.
Measured: measured at day 0,1, 3, 28 post surgery
Characterize the phenotype of dysfunctional CD8+ T cells in the immediate postoperative period
Using multicolor flow cytometry, we characterized the cell surface markers, intracellular pathways and cytokines that are altered on POD1 in CD8+ T cells in response to RBD antigen.
Measured: measured at day 0,1 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start5 Jul 2023
- Primary completion6 Jun 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Auer, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925906
- Sponsor's protocol ID
- OHSNREB# 2011884-01H-CD8+-2025
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen
- ClinicalTrials.gov ID
- NCT06925906
- Acronym / sponsor ID
- OHSNREB# 2011884-01H-CD8+-2025
- Conditions
- Abdominal Cancer
- Keywords
- Suppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 13 Apr 2025 (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.
The Auer Lab research program studies how surgery affects the immune system and how this can lead to suppression in cancer patients which can lead to cancer reoccurrence. This has been well characterized in literature, with a clear demonstration that both surgery induced suppression of T cell and Natural Killer (NK) cell result in cancer recurrence..
The present study is the first in humans, to our knowledge, to demonstrate antigen specific dysfunction in T cells and B cells following cancer surgery. The study capitalized on the widespread vaccination of cancer patients against COVID before surgery, which allowed us to measure the response to the antigen S protein of SARS-CoV2. While the study is translational in methodology, we believe it will be of significant interest to all surgeons because it clearly establishes that surgery profoundly suppresses antigen-specific T and B cell responses, which have implications for postoperative infectious complications and cancer recurrence for those patients undergoing tumor resection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with Abdominal cancers | – | –Cancer patients who have been vaccinated with 2 or more doses of the Pfizer BNT162b1 vaccine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ottawa Hospital Cancer patients undergoing abdominal surgeries
Key inclusion criteria (6 listed)
- Patients with a diagnosis of a primary abdominal malignancy consented to undergo major surgery with a planned length of stay of 3 or more days.
- Eligible patients must have signed a consent for surgical resection of the malignancy.
- Adequate hematological function defined as: platelet count ≥ 100 x 109/L, absolute neutrophil count ≥ 1 x 109/L, white blood count ≥ 2.5 x 109/L, hemoglobin count ≥ 90 g/L.
- Adequate organ functioning, including: total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST, ALT < 2.5 x ULN; INR <1.5 ; CrCl>30mL/min.
- Ability to understand and provide a signed informed consent form (ICF) approved by the Institutional Review Board (IRB/IEC/REB).
Key exclusion criteria (7 listed)
- Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (<7.5 mg daily).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantify the degree and determine the postoperative time course of antigen-specific T cell dysfunction following surgery
Time frame: measured at day 0,1, 3, 28 post surgery
Used the production of IFNγ, as measured by ELISpot, to determine the degree and duration of surgery-induced suppression of T cell responses to the RBD antigen.
Characterize the phenotype of dysfunctional CD8+ T cells in the immediate postoperative period
Time frame: measured at day 0,1 post surgery
Using multicolor flow cytometry, we characterized the cell surface markers, intracellular pathways and cytokines that are altered on POD1 in CD8+ T cells in response to RBD antigen.
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 13 Apr 2025.
- Pre published article of the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Auer principal investigator
The Ottawa Hospital
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 Abdominal Cancer, 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 6 inclusion and 7 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 13 Apr 2025. 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?
Quantify the degree and determine the postoperative time course of antigen-specific T cell dysfunction following surgery (time frame: measured at day 0,1, 3, 28 post surgery). The study lists 2 primary outcomes in all. 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 13 Apr 2025; AzTrials last refreshed its copy on 4 Nov 2026.