Status:
COMPLETED
Characterizing Postoperative T and B Cell Dysfunction in Cancer Surgery Patients, Using COVID-19 as a Model Antigen
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Abdominal Cancer
Eligibility:
All Genders
18-85 years
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 characteri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 18 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06925906
Start Date
July 5 2023
End Date
August 18 2024
Last Update
April 13 2025
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6