Brain NeoplasmNCT04553757
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma
An observational study of Brain Neoplasm and Low Grade Glioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Neoplasm, Low Grade Glioma, Seizure Disorder
- What is being tested?
- Survey Administration
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2020to 30 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary brain tumors with a history of seizures secondary to brain tumor.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point.
SECONDARY OBJECTIVES:
- 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
- Brain Neoplasm, Low Grade Glioma, Seizure Disorder
- Being tested
- Survey Administration
- Medical subject headings
- Brain Neoplasms, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Patients complete a seizure assessment survey over 5 minutes at each clinic visit. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (3)
Patient data collection
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.
Measured: Up to 2 years
Progression-free survival (PFS)
Will evaluate PFS when compared with seizure control.
Measured: Up to 2 years
Overall survival (OS)
Will evaluate OS when compared with seizure control.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start8 Jul 2020
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ashley Aaroe, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553757
- Sponsor's protocol ID
- 2020-0124
- Other IDs
- NCI-2020-06510, 2020-0124
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No