Adverse Radiation EffectsMICRO-ARE-SRSNCT07767981
Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery
An observational study of Adverse Radiation Effects and Radiation Necrosis, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Radiation Effects, Radiation Necrosis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 5 Sep 2028
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Admitted to the University of Chicago Medical Center
- Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis
- Able to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Sean Polster, MD, 773-702-2123, spolster@uchicago.edu
Justine Lee, BSN, RN, 7738341485, justinelee89@uchicagomedicine.org
About this study
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
- Medical subject headings
- Neurotoxicity Syndromes, Radiation Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From stereotactic radiosurgery through 2.5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start5 Aug 2025
- Primary completion5 Aug 2027 (estimated)
- Study completion5 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Radiation EffectsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767981
- Sponsor's protocol ID
- IRB25-0303
- Acronym
- MICRO-ARE-SRS
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Determinants of Adverse Effects of Stereotactic Radiosurgery
- ClinicalTrials.gov ID
- NCT07767981
- Acronym / sponsor ID
- MICRO-ARE-SRS / IRB25-0303
- Conditions
- Adverse Radiation Effects, Radiation Necrosis
- Keywords
- Stereotactic Radiosurgery, Adverse Radiation Effects, Radiation Necrosis, Gut Microbiome, Microbiome, Metabolomics, Fecal Metabolomics, Blood Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 5 Aug 2027 (estimated)
- Study completion
- 5 Sep 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Admitted to the University of Chicago Medical Center
- Receiving stereotactic radiosurgery as standard of care for their presumed diagnosis
- Able to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Radiation Effects and Radiation Necrosis, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Radiation Necrosis Following Stereotactic Radiosurgery (time frame: From stereotactic radiosurgery through 2.5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.