跳至主要内容
临床试验/NCT03055364
NCT03055364已完成不适用

Observational Study Evaluating Neurocognitive Function in Patients With Primary CNS Malignancy Receiving Radiation Treatment to the Brain

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2017年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
129
试验地点
1
主要终点
characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent

研究概览

简要总结

In this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. The investigators will use the CogState software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. Cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. Data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. In addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 4 years with primary CNS malignancy
  • Able to use computer for assessment battery
  • Receiving photon- or proton-based radiation for primary intracranial malignancy
  • Demonstrates the capacity to sign informed consent

排除标准

  • Patients with WHO Grade IV tumors

结局指标

主要结局

characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent

时间窗: baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy

Using the CogState software

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadia N. Laack, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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