Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery

NCT07767981 | Recruiting

• 1 other identifier: IRB25-0303
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Radiation Effects; Radiation Necrosis

Keywords

Stereotactic Radiosurgery; Adverse Radiation Effects; Radiation Necrosis; Gut Microbiome; Microbiome; Metabolomics; Fecal Metabolomics; Blood Metabolomics; Biomarkers; Neurotoxicity; Radiation Toxicity; Neuro-Oncology; Brain Radiation

Outcome Measures

Primary Outcomes (1)

• 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.

  From stereotactic radiosurgery through 2.5 years of follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients receiving stereotactic radiosurgery at the University of Chicago Medical Center as part of standard clinical care for their presumed diagnosis. Participants will be prospectively enrolled and followed longitudinally to evaluate changes in the gut microbiome and metabolomic profiles and their relationship with adverse effects following stereotactic radiosurgery.

You may qualify if:

• Admitted to the University of Chicago Medical Center
• Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Neurotoxicity Syndromes; Radiation Injuries

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 5, 2027
• Study Completion (Estimated): September 5, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

US (1)