Adverse Radiation Effects, Radiation Necrosis
Conditions
Keywords
Stereotactic Radiosurgery, Adverse Radiation Effects, Radiation Necrosis, Gut Microbiome, Microbiome, Metabolomics, Fecal Metabolomics, Blood Metabolomics, Biomarkers, Neurotoxicity, Radiation Toxicity, Neuro-Oncology, Brain Radiation
Brief summary
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.
Interventions
None listed
Sponsors
University of Chicago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radiation Necrosis Following Stereotactic Radiosurgery | From stereotactic radiosurgery through 2.5 years of follow-up | 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. |
Countries
United States
Outcome results
None listed