Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-26 @ 7:55 PM
Study NCT ID:
NCT04553757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-24
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: