An observational study in Adverse Radiation Effects and Radiation Necrosis, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Chicago · Observational
Among 76 studies in Neurotoxicity Syndromes with a site in United States — 6 open to participants now, 11 under way, 3 of them phase 3. Neurotoxicity Syndromes · United States.
Among the 76 studies in Neurotoxicity Syndromes with a site in United States, this one is the 4th largest by planned enrollment of the 23 observational ones, is one of 2 that started in 2025, is one of 23 observational ones, reaches primary completion later than 7 of the 10 other live ones, and was the 76th registered.
133 studies on the registry are indexed under Neurotoxicity Syndromes; 17 are open to participants now.
This study's planned enrollment of 150 is above the median of 81 across 42 observational studies indexed under Neurotoxicity Syndromes.
Browse Neurotoxicity Syndromes studies →6 of the 76 studies in Neurotoxicity Syndromes with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 15 Neurotoxicity Syndromes studies recruiting now, 11 (73%) set no upper age limit and 1 (7%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →76 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 2 started in 2025.
Median enrollment 85 across the 52 interventional studies, 76 across the 23 observational. Of the 61 that completed or were terminated, 28 (46%) have results posted.
2 of 76 have an industry lead sponsor. The 10 most frequent:
University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
University of Chicago has 1 study filed under Neurotoxicity Syndromes — fewer than ten, so there is no comparison to draw.
6 of the studies in Neurotoxicity Syndromes with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00978458Phase 3Eastern Cooperative Oncology GroupRadiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma | 2026-12-31 |
| NCT06950190Phase 3Ellis MedicineEvaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) | 2027-02-20 |
| NCT06144151M.D. Anderson Cancer CenterA Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity | 2027-04-01 |
| NCT07767981University of ChicagoMicrobiome Determinants of Adverse Effects of Stereotactic Radiosurgery | 2027-08-05 |
| NCT07095998Ka-Wai HoNerve Excitability in Cisplatin-Induced Peripheral Neuropathy | 2027-08-30 |
Among the 76 studies in Neurotoxicity Syndromes with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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-up
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Aug 2027, 24 months after the start.
Of 20 observational studies under Neurotoxicity Syndromes, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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