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

Brain Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04553757
• Other study ID #: 2020-0124
• Secondary ID: NCI-2020-0651020
• Status: Active, not recruiting
• Start date: July 8, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms
• Epilepsy
• Glioma
• Low Grade Glioma
• Seizure Disorder
• Seizures

Intervention

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 2 years
Primary	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.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	Progression-free survival (PFS)	Will evaluate PFS when compared with seizure control.	Up to 2 years
Secondary	Overall survival (OS)	Will evaluate OS when compared with seizure control.	Up to 2 years

External Links

•   MD Anderson Cancer Center Website