Tumor Immunotherapy and Microbiome Analysis (TIME)

Sunnybrook Health Sciences Centre

Status

Enrolling

Conditions

Advanced Solid Tumor

Study type

Observational

Funder types

Other

Identifiers

NCT04579978

TIME

Details and patient eligibility

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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