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.
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 Type
OBSERVATIONAL
Enrollment
60
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGRelative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing
Time frame: 6 months
Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing; IgA sequencing of fecal samples from patients who develop diarrhea/colitis
Time frame: 12 months
Changes in the composition of the intestinal microbiome induced by ICIs
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing
Time frame: 6 months
Relative abundance of bacterial DNA in peripheral blood samples
Blood microbial abundance measured via qPCR
Time frame: 6 months
Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition
Flow cytometry of blood at baseline and at development of progressive disease and analysis of microbiome composition at baseline and at development of progressive disease
Time frame: 2 years
Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition
Analysis of serum metabolites using chromatography coupled to tandem mass spectrometry
Time frame: 6 months
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