Tumor Immunotherapy and Microbiome Analysis
Sponsored by Sunnybrook Health Sciences Centre
About this trial
Last updated 3 years ago
Study ID
TIME
Status
Recruiting
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 5 months ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- Sign written and voluntary informed consent
- Adult patients aged >=18, male or female
- Eastern Cooperative Group (ECOG) performance status 0-2
- Histologic diagnosis of an advanced/unresectable or metastatic solid tumor
- Measurable disease as per RECIST 1.1 criteria
- Be suitable for or receiving ICI treatment
- Prior immunotherapy allowed
- Be willing and able to provide fecal and blood specimens for analysis as per protocol
Exclusion Criteria
- Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
Locations
Location
Status
Recruiting