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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06510 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0124 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (survey) | Patients complete a seizure assessment survey over 5 minutes at each clinic visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Administration | Other | Complete survey |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary brain tumors with a history of seizures secondary to brain tumor.
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Aaroe, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Up to 2 years |
| Progression-free survival (PFS) | Will evaluate PFS when compared with seizure control. | Up to 2 years |
| Overall survival (OS) | Will evaluate OS when compared with seizure control. | Up to 2 years |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |