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

N/AActive Not RecruitingNCT04553757

M.D. Anderson Cancer Center100 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Brain Neoplasm Low Grade Glioma Seizure Disorder

Interventions

Survey AdministrationOTHER

Complete survey

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Rate of change of seizure frequency

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.

Time frame: Baseline to 2 years

Status of tumor

Radiographic information will be derived from brain MRIs performed on each patient at time of diagnosis, and subsequently at times of survey administration. 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.

Time frame: Up to 2 years

Secondary Outcomes

Patient data collection

Will obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control. Clinical information to be extracted from the medical record includes but not limited to; date of birth, gender, date of diagnosis, clinical symptoms referable to the brain tumor, functional status and age at diagnosis, treatments applied, dates of progression, and date of death. Radiographic information will be derived from brain MRIs performed on each patient at time of diagnosis, and subsequently at times of survey administration. Will perform descriptive statistics to characterize the demographic and disease-related features of this population.

Time frame: Up to 2 years

Progression-free survival (PFS)

Will evaluate PFS when compared with seizure control.

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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