NCT07767981 Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery
| NCT ID | NCT07767981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Adverse Radiation Effects |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2027-08-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-08-05 with a primary completion date of 2027-08-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07767981 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adverse Radiation Effects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07767981 currently recruiting?
Yes, NCT07767981 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Chicago to inquire about joining.
Where is the NCT07767981 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07767981 clinical trial?
NCT07767981 is sponsored by University of Chicago. The trial plans to enroll 150 participants.