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

NCT04553757 | Active Not Recruiting

• 2 other identifiers: 2020-0124NCI-2020-06510
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasm; Low Grade Glioma; Seizure Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Patient data collection

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

Observational (survey)

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

Other: Survey Administration

Interventions

Survey Administration OTHER

Complete survey

Observational (survey)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary brain tumors with a history of seizures secondary to brain tumor.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Brain Neoplasms; Epilepsy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ashley Aaroe, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: July 8, 2020
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)