Tumor Immunotherapy and Microbiome Analysis

Advanced Solid Tumor Clinical Trial

— TIME  

Official title:

Tumor Immunotherapy and Microbiome Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04579978
• Other study ID #: TIME
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: Rossanna C. Pezo, MD/PhD
• Phone: 416-480-4757
• Email: rossanna.pezo[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Princess Margaret Hospital, Canada, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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