Clinical trial NCT06925906: Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen
Official title: Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Cancer
Keywords: Suppression
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ottawa Hospital Cancer patients undergoing abdominal surgeries

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quantify the degree and determine the postoperative time course of antigen-specific T cell dysfunction following surgery
timeFrame: measured at day 0,1, 3, 28 post surgery
measure: Characterize the phenotype of dysfunctional CD8+ T cells in the immediate postoperative period
timeFrame: measured at day 0,1 post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Rebecca Auer
role: PRINCIPAL_INVESTIGATOR
References: