Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen

NCT06925906 | Completed DMC

• 1 other identifier: OHSNREB# 2011884-01H-CD8+-2025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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) 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

Outcome Measures

Primary Outcomes (2)

• 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 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 at day 0,1 post surgery

Study Arms (1)

Cancer patients with Abdominal cancers

Cancer patients who have been vaccinated with 2 or more doses of the Pfizer BNT162b1 vaccine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ottawa Hospital Cancer patients undergoing abdominal surgeries

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Links

• Pre published article of the study.

Study Officials

• Rebecca Auer

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 13, 2025
• Study Start: July 5, 2023
• Primary Completion: June 6, 2024
• Study Completion: August 18, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)