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Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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