Status:
RECRUITING
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
Lead Sponsor:
University Health Network, Toronto
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Brief Summary
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 immu...
Detailed Description
Accumulating evidence supports that differential composition of fecal microbiome influences response to immunotherapy and development of colitis. Microbiome with different profiles are also associated...
Eligibility Criteria
Inclusion
- Signed written and voluntary informed consent.
- Patient must be willing and able to provide collection for blood and stool specimen analysis at the pre-specified time-points.
- Age \> 18 years, male or female.
- Patient must be diagnosed with any advanced solid tumor deemed incurable and to be treated at Princess Margaret Cancer Centre.
- Patients must be eligible to treatment with an IO combination.
Exclusion
- Any conditions that in the opinion of the Investigator would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
- History of autoimmune disease with a flare episode within one year before study screening.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 5 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04107311
Start Date
September 5 2019
End Date
March 5 2026
Last Update
July 2 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9