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Active (not recruiting) NCT04553757

Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma

Conditions: Brain Neoplasm Low Grade Glioma Seizure Disorder

Sponsor: M.D. Anderson Cancer Center

trial.available_in: БГ
Overview
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point. SECONDARY OBJECTIVES: I. To obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control. II. Evaluate progression free survival and overall survival when compared with seizure control. OUTLINE: Patients complete a seizure assessment survey over 5 minutes at each clinic visit.
Who can participate
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
Interventions
Survey Administration
OTHER
Locations 1
United States (1)
M D Anderson Cancer Center
Houston , Texas
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
08.07.2020
Completion date
30.12.2027
Registry ID
NCT04553757
Source
clinicaltrials.gov
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