Advanced Solid Tumor Clinical Trial
— TIMEOfficial title:
Tumor Immunotherapy and Microbiome Analysis
NCT number | NCT04579978 |
Other study ID # | TIME |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Princess Margaret Hospital, Canada, University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relative 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 | 6 months | |
Primary | 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 | 12 months | |
Secondary | Changes in the composition of the intestinal microbiome induced by ICIs | Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing | 6 months | |
Secondary | Relative abundance of bacterial DNA in peripheral blood samples | Blood microbial abundance measured via qPCR | 6 months | |
Secondary | 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 | 2 years | |
Secondary | Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition | Analysis of serum metabolites using chromatography coupled to tandem mass spectrometry | 6 months |
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