Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery

University of Chicago150 enrolled

Overview

This prospective observational study will investigate the relationship between the gut microbiome and adverse effects following stereotactic radiosurgery (SRS). Patients undergoing SRS as part of their standard clinical care will provide blood and stool samples before treatment and during follow-up. Samples will be analyzed to characterize fecal and blood metabolomic profiles and changes in the gut microbiome over time. The study has two primary objectives: to determine how stereotactic radiosurgery affects the gut microbiome and associated metabolomic profiles, and to evaluate whether microbiome- and metabolite-associated features are related to the development of adverse effects following SRS. Clinical data and standard-of-care neuroimaging will be collected longitudinally to identify outcomes including radiation necrosis and other adverse radiation effects. Biological profiles from patients who develop these outcomes will be compared with those from patients who do not, as well as within individual patients over time. The study aims to identify microbiome and metabolic signatures associated with susceptibility to adverse effects of stereotactic radiosurgery, with the long-term goal of improving risk stratification and informing future approaches to monitoring and treatment.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Adverse Radiation Effects Radiation Necrosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Admitted to the University of Chicago Medical Center * Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis * Able to provide informed consent Exclusion Criteria: * Anticipated survival of less than 6 months * Known or suspected infectious colitis within the month prior to enrollment * Rectal disease that prevents fecal sampling * Foreseeable inability to complete the study

Outcomes

Primary Outcomes

Number of Participants With Radiation Necrosis Following Stereotactic Radiosurgery

Radiation necrosis will be identified through review of standard-of-care follow-up neuroimaging obtained after stereotactic radiosurgery. The outcome will be reported as the number of participants who develop radiation necrosis during the 2.5-year follow-up period.

Time frame: From stereotactic radiosurgery through 2.5 years of follow-up