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

NCT ID: NCT04553757

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-08

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Brain Neoplasm Low Grade Glioma Seizure Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational (survey)

Patients complete a seizure assessment survey over 5 minutes at each clinic visit.

Survey Administration

Intervention Type OTHER

Complete survey

Interventions

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Survey Administration

Complete survey

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Aaroe, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2020-06510

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0124

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0124

Identifier Type: -

Identifier Source: org_study_id

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