Clinical trial · Observational
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
NCT04553757CI-TRIAL-00109147active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigates how seizures can vary over time with changes in low grade gliomas and its treatments. This study may help doctors find symptoms or triggers of seizures earlier than normal, and ultimately earlier care or treatment for seizures.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasm | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Low Grade Glioma | Low Grade Glioma | ONTOLOGY_EXACT | 0.98 |
| Seizure Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (survey)
- description
- Patients complete a seizure assessment survey over 5 minutes at each clinic visit.
- interventionNames
- Other: Survey Administration
Primary outcomes (2)
- measure
- Rate of change of seizure frequency
- timeFrame
- Baseline to 2 years
- description
- Both average composite scores as well as individual question scores from the seizure survey will be evaluated. Will perform descriptive statistics to characterize the demographic and disease-related features of this population. Will perform regression analyses to the relationship of survey results to clinical and radiographic features. Cox regression analyses for other relevant post-hoc analyses may be performed.
- measure
- Status of tumor
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Adult patients * Primary brain tumors (separated by World Health Organization \[WHO\] grade I-IV) * History of seizures secondary to brain tumor * On tumor directed treatment * Magnetic resonance imaging (MRI) within 2 weeks of clinic visit where seizure assessment takes place Exclusion Criteria: * Patients without seizures * Patients with intracranial lesions other than primary brain tumor * Patients not undergoing tumor directed treatment * Absence of recent (within 2 weeks) MRI
References
Publications (0)
Data not yet available
No reference posted for this study.