Actively Recruiting
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Led by University Health Network, Toronto · Updated on 2025-07-02
120
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, investigator-initiated, non-interventional study evaluating the role of the intestinal microbiome and autoimmune panels as a predictor for developing ≥ Grade 2 CTCAE v5.0 immune-related adverse event (irAE) and/or requiring systemic immunosuppression for irAEs in advanced solid tumor patients receiving immunooncology (IO) combinations at the Princess Margaret Cancer Centre. This is a minimal risk study involving the analysis of patient samples and does not involve therapeutic intervention. The study will involve a prospective cohort of up to 120 patients and it is anticipated that patient accrual will be completed within 18 months. Patients will receive IO combination as per their specific protocols from their other clinical trial or per their standard of care and samples will be collected at multiple time-points. No additional visits to the hospital will be needed for this study as safety assessments are already captured for all patients based on their participation in a clinical trial or per their standard of care.
CONDITIONS
Official Title
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written and voluntary informed consent.
- Willing and able to provide blood and stool specimens at specified time-points.
- Age over 18 years, male or female.
- Diagnosed with any advanced solid tumor considered incurable and treated at Princess Margaret Cancer Centre.
- Eligible to receive immunooncology combination therapy.
You will not qualify if you...
- Any condition that the Investigator believes would affect patient safety or interfere with specimen evaluation and study results.
- History of autoimmune disease with a flare episode within one year before study screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
A
Anna Spreafico, MD
CONTACT
A
Aileen Trang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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