Analyzing gut bacteria and autoimmune markers to predict side effects in cancer patients receiving immunotherapy
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
This study is testing if the bacteria in the gut and certain blood markers can help predict side effects in cancer patients receiving immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04107311 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates how the intestinal microbiome and autoimmune panels can predict the risk of immune-related adverse events (irAEs) in patients with advanced solid tumors undergoing immunotherapy at the Princess Margaret Cancer Centre. It involves a cohort of up to 120 patients who will provide blood and stool samples at various time points during their treatment. The study aims to identify correlations between microbiome composition, autoimmune markers, and the development of serious side effects from immunotherapy. No additional hospital visits are required as safety assessments are already part of the standard care for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced solid tumors who are eligible for immunotherapy at the Princess Margaret Cancer Centre.
Not a fit: Patients with a history of autoimmune disease experiencing a flare within the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk for severe side effects from immunotherapy, allowing for better management and personalized treatment strategies.
How similar studies have performed: While there is accumulating evidence regarding the role of the microbiome in immunotherapy responses, this specific approach of correlating microbiome and autoimmune panels with irAEs is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed written and voluntary informed consent. 2. Patient must be willing and able to provide collection for blood and stool specimen analysis at the pre-specified time-points. 3. Age \> 18 years, male or female. 4. Patient must be diagnosed with any advanced solid tumor deemed incurable and to be treated at Princess Margaret Cancer Centre. 5. Patients must be eligible to treatment with an IO combination. Exclusion Criteria: 1. 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. 2. History of autoimmune disease with a flare episode within one year before study screening.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Anna Spreafico, MD — Princess Margaret Cancer Centre
- Study coordinator: Anna Spreafico, MD
- Email: tip@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.