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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553757
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Brain Neoplasm Low Grade Glioma Seizure Disorder Other: Survey Administration

Detailed Description:

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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Study Type : Observational
Estimated 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 : July 8, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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




Primary Outcome Measures :
  1. Rate of change of seizure frequency [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 2 years ]
    Will evaluate PFS when compared with seizure control.

  3. Overall survival (OS) [ Time Frame: Up to 2 years ]
    Will evaluate OS when compared with seizure control.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary brain tumors with a history of seizures secondary to brain tumor.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553757


Contacts
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Contact: Rebecca A Harrison 713-792-1263 raharrison@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Rebecca A. Harrison    713-792-1263      
Principal Investigator: Rebecca A. Harrison         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rebecca A Harrison M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04553757    
Other Study ID Numbers: 2020-0124
NCI-2020-06510 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0124 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Brain Neoplasms
Seizures
Epilepsy
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neurologic Manifestations
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases