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临床试验/CTRI/2024/02/062605
CTRI/2024/02/062605招募中不适用

Incidence of seizures after treatment completion and practice Patterns of anti-convulsant therapy in supratentorial brain tumors: an observational study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Incidence of seizure

研究概览

简要总结

Primary brain tumors denote tumors originating inside the brain substance. Patients with primary brain tumors often develop seizures during diagnosis orduring the course ofthe disease. Antiepileptic drugs (AED) are used to reduce the risk of the development of seizures, both in patients with a previous history of seizures or without prior history (as prophylaxis). There are no well-established guidelines regarding the appropriate use of AEDs, choice of drugs, or duration of use. The practice pattern of AED is highly variable across different institutions. The most common AED in India (as obtained from a national survey) and also in our institution include levetiracetam. Other commonly used AEDs include phenytoin, brivaracetam, clobazam, and carbamazepine. Since a majority of patients are referred to our tertiary care center following the diagnosis of a brain tumor or after surgery, they are already on AEDs as per the preference of the primary physician. In our institution, we stop AED once the patient is free from any seizures for a duration of seizures. In the current observational study, we will include patients with primary brain tumors who have completed standard treatment for their disease. Patients accrued in the study will be followed up for a duration of 3 years, with brief interviews scheduled to record the use of AED and any seizure episodes. No additional visits are required for the current study, with the information collected during follow-up visits as per standard institutional practice. The study will have no influence on the treatment or use of AEDs (either drugs, duration, or discontinuation). Different clinical characteristics will be analyzed to understand the factors influencing the occurrence of seizures after treatment completion.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Primary brain tumor with supratentorial location Completed scheduled upfront treatment (Surgery or radiation or chemotherapy) Age more than 18 years during diagnosis Clinically and or radiologically controlled disease during study accrual.

排除标准

  • Age less than 18 years during diagnosis of brain tumor Infratentorial location Primary spinal tumor Patient with severe memory deficit and cannot recall prior history Brain metastasis.

结局指标

主要结局

Incidence of seizure

时间窗: baseline and 6monthly upto 2yrs

次要结局

  • Progression free survival(Till the time of disease progression)
  • Overall survival(At the completion of study)
  • Factors influencing the incidence of seizures(after treatment completion)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tejpal Gupta

Tata Memorial Hospital

研究点 (1)

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