Neurocognitive Risks in Children With Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.
研究概览
简要总结
The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors.
Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 6 to 16 years and 11 months during the study period
- •Type of pathology: solid tumor
- •Place of treatment and follow-up: Gustave Roussy
- •Minimum time from the end of the initial treatment:
- •For patients who have not received treatment with methotrexate: 6 months
- •For patients being treated with methotrexate: none
- •Obtaining the non-opposition of parents / legal representatives
- •Affiliation to a social security scheme.
排除标准
- •Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...)
- •Patients lost to follow-up
- •Deceased patients
- •Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment)
- •Non-French speaking patients
结局指标
主要结局
Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received.
时间窗: Up to 60 months
Univariate analysis to identify risk factors related to cognitive disorders.
时间窗: Up to 60 months
Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors.
时间窗: Up to 60 months
次要结局
未报告次要终点