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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04553757
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ashley Aaroe, MD
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Neoplasm, Low Grade Glioma, Seizure Disorder
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: Observational (survey)

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

Interventions

Other: - Survey Administration

Complete survey

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Ashely Aaroe, MD

[email protected]

713-563-8705