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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04553757
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 29.7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Neoplasm; Low Grade Glioma; Seizure Disorder	Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVE:

1. To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point.

SECONDARY OBJECTIVES:

1. 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.

2. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
• Actual Study Start Date: Jul 8, 2020
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observational (survey) Patients complete a seizure assessment survey over 5 minutes at each clinic visit.	Other: Survey Administration; Complete survey

Outcome Measures

Primary Outcome Measures

1. Rate of change of seizure frequency [Baseline to 2 years]

   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.

2. Status of tumor [Up to 2 years]

   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.

Secondary Outcome Measures

1. Patient data collection [Up to 2 years]

   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.

2. Progression-free survival (PFS) [Up to 2 years]

   Will evaluate PFS when compared with seizure control.

3. Overall survival (OS) [Up to 2 years]

   Will evaluate OS when compared with seizure control.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Rebecca A Harrison, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04553757
• Other Study ID Numbers: 2020-0124; NCI-2020-06510; 2020-0124
• First Posted: Sep 17, 2020
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioma; Brain Neoplasms; Seizures; Epilepsy

Study Results

No Results Posted as of Apr 25, 2022