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Clinical Trial Summary

The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumor types. The aim of this study is to examine the gut microbiome composition in patients undergoing standard of care treatment for advanced/unresectable and/or metastatic solid tumors with ICIs. Fecal samples and peripheral blood samples will be collected to further characterize the diversity of gut bacteria and to study potential mechanisms by which gut bacteria impact the immune response.


Clinical Trial Description

This is a prospective study of gut microbial markers. Patients with histologically confirmed advanced/unresectable or metastatic solid tumors who are planned to initiate standard of care ICIs or are undergoing standard of care treatment with ICIs will be approached for participation in the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04579978
Study type Observational
Source Sunnybrook Health Sciences Centre
Contact Rossanna C. Pezo, MD/PhD
Phone 416-480-4757
Email rossanna.pezo@sunnybrook.ca
Status Recruiting
Phase
Start date April 1, 2018
Completion date December 2024

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