Who is eligible for clinical trial NCT04107311?

Participants must meet protocol criteria for Solid Tumor. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04107311 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-06

Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients (NCT04107311)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University Health Network, Toronto

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (3 items).

Location: Princess Margaret Cancer Centre — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Princess Margaret Cancer Centre — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗