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临床试验/NCT05254197
NCT05254197招募中不适用

The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Tumor volume in each MRI

研究概览

简要总结

The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had magnetic resonance (MR) re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. In all MRs taken by patients, the date of imaging and the volume of the tumor are measured, and we aim to establish a natural growth history for non-malignant brain tumors.

详细描述

Non-malignant central nervous system (CNS) tumor accounts for 70% of all primary CNS tumors, and over 300,000 patients were diagnosed with non-malignant CNS tumor per year in the United States. Not much is known about the natural history of non-malignant CNS tumors, as it is often treated immediately upon detection. However, some of them, especially small and asymptomatic non-malignant CNS tumors should not be treated immediately upon diagnosis but are observed and followed-up by repeated magnetic resonance imaging (MRI). This study aims to make a prospective cohort of non-malignant CNS tumors that do not require immediate treatment and to quantitatively analyze which factors are related to the growth of tumors.

The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had MR re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed neoplasms of CNS WHO grade 2 or lower among primary intracranial tumors and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Tumor volume in each MRI

时间窗: within 15 years after enrollment

Measured tumor volume in each MRI

T2 signal intensity of tumor in each MRI

时间窗: within 15 years after enrollment

T2 signal intensity of tumor as a ratio to contralateral white matter

次要结局

  • Pre-treatment follow-up period for patients who eventually received treatment(within 15 years after enrollment)
  • Growth rate of tumor volume between MR exams (absolute volume)(within 15 years after enrollment)
  • Growth rate of tumor volume between MR exams (volume ratio)(within 15 years after enrollment)
  • Number of patients who eventually received treatment(within 15 years after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chul-Kee Park

Professor

Seoul National University Hospital

研究点 (1)

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