Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to the University of Chicago Medical Center
Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis
Able to provide informed consent
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
From stereotactic radiosurgery through 2.5 years of follow-upSponsors and contacts
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Source ClinicalTrials.gov