NCT03208387进行中（未招募）不适用
Biological Substrates of Impaired Neurocognitive Functioning: Understanding the Late Effects of Surviving a Pediatric Brain Tumor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Feasibilty which is the number of eligible survivors consented per month
研究概览
简要总结
The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children Treated for Posterior Fossa Tumors:
- •As per medical record or clinical report, successfully completed all medical treatment for either an M0 posterior fossa medulloblastoma without dissemination or posterior fossa low-grade astrocytoma without relapse or evidence of residual disease.
- •For medulloblastoma survivors only: Previously treated with gross total resection (GTR), craniospinal irradiation with conformal posterior fossa boost radiotherapy (CSI + Boost) and chemotherapy
- •For low grade astrocytoma survivors only: Previously treated with gross total resection ONLY (no chemotherapy or radiotherapy).
- •As per medical record or clinician report, between 1-10 years post completion of their medical treatment for their posterior fossa brain tumor.
- •Subject is between the ages of 6 through 16 years at time of consent.
- •As per medical record or parent report, subject is able to tolerate an MRI without sedation.
- •Healthy Control Participants:
- •No major medical illness, as determined by medical interview by study physician.
- •As per parent report, subject is between the ages of 6 through 16 years at time of consent.
- •As per parent report, subject is able to tolerate an MRI without sedation.
排除标准
- •All Participants:
- •Full Scale IQ as documented to be below a standard score of <70 based upon the study IQ assessment completed after consent.
- •As per self or parent report, completed any portion of the neuropsychological battery used in this study within the last year.
- •MRI contraindications (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures.
- •As per self or parent report or medical record, currently taking medications that have CNS effects (i.e., antidepressants, neuroleptics, anti-seizure medications, drugs that affect blood pressure or heart rate, alpha-agonists, adrenergic blockers, lithium, sedating antihistamines, and some medications for the treatment of asthma).
- •As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.
结局指标
主要结局
Feasibilty which is the number of eligible survivors consented per month
时间窗: 2 years
The study is a pilot study to collect information on feasibility broadly defined. The feasibility indicators are primarily descriptive variables, including a careful monitoring of accrual rate (how many eligible survivors consented per month).
次要结局
未报告次要终点
研究者
研究点 (4)
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