NCT01305122终止不适用
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 112
- 试验地点
- 41
- 主要终点
- MoCA test
研究概览
简要总结
This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years.
- cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)
- cohort B: patients with disease simple monitoring.
The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OMS grade II glioma
- •signed informed consent
- •age >=18
- •IK >=80%
- •ability to read, write and undertand French
排除标准
- •glioma localized to brainstem
- •other neurologic or psychiatric disease
- •history of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization
- •neuroleptic concomitant treatment
- •pregnant or lactating women
结局指标
主要结局
MoCA test
时间窗: 36 months
次要结局
未报告次要终点
研究者
研究点 (41)
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