NCT03599830已完成不适用
Study of the Cognition of Patients Treated With
Centre Francois Baclesse5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年7月10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
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Change in cognitive function (at least in a cognitive domain)
研究概览
简要总结
The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology.
Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer.
The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient over the age of 18,
- •Patient with cancer and having to initiate treatment with immunotherapy alone
- •Treatment with immunotherapy will include either an anti-PD1 / L1 or Anti CTLA4 monotherapy or combination,
- •Patients may have received other antitumor treatments other than immunotherapy but these should be stopped at the time of initiation of immunotherapy
- •Performance Status <2
- •Patient at the level of studies 3 "end of primary studies" minimum (Barbizet scale),
- •Mastery of the French language.
- •Patient affiliated to a social security system
- •Patient having attested in writing of his non-opposition to participate in the study
排除标准
- •Previous treatment with immunotherapy
- •Another anti-tumor treatment underway
- •Primary cancer of the central nervous system or cerebral metastasis, symptomatics and not controlled
- •Abuse of alcohol or drug use
- •Severe visual and / or auditory deficiency,
- •Refusal of participation of the patient.
- •Patient deprived of liberty or under guardianship
- •Patient unable to follow the study for geographical, social or psychopathological reasons
结局指标
主要结局
Change in cognitive function (at least in a cognitive domain)
时间窗: between inclusion and 3 months.
The proportion of patients who will have a reduction of scores in neuropsychological questionnaires (scores of MoCA2, Hopkins verbal learning test, WAIS-IV, Trail Making test, Stroop Symboles)
次要结局
未报告次要终点
研究者
研究点 (5)
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