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NCT Number: NCT07767981

Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Radiation Necrosis Following Stereotactic Radiosurgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: MICRO-ARE-SRS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 17, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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