Spots Global Cancer Trial Database for Tumor Immunotherapy and Microbiome Analysis

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Trial Identification

Brief Title: Tumor Immunotherapy and Microbiome Analysis

Official Title: Tumor Immunotherapy and Microbiome Analysis

Study ID: NCT04579978

Conditions

Advanced Solid Tumor

Interventions

Study Description

Brief 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.

Detailed 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.