NCT01336231终止不适用
Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study
Centre Francois Baclesse5 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2008年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 82
- 试验地点
- 5
- 主要终点
- Impact of fatigue, memory problems and attentional
研究概览
简要总结
Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 (e) Age (e) over 18 years
- •Kidney cancer metastatic or locally advanced
- •Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together
- •Proposed treatment in first line or second line
- •Brain imaging not finding brain metastases
- •Having signed the informed consent of study participation
- •The patient may have received prior anti-angiogenic
排除标准
- •Cancer of the kidney other than primitive
- •Previous history of cancer other than kidney cancer in complete remission for less than 5 years
- •Patients under 18 years
- •Patients whose treatment is associated with chemotherapy
- •disorders of cognitive functions to existing treatment delivery
- •Pathology psychiatric evolutionary
- •Refusal of participation
- •Patient unable to respond to cognitive tests
- •Heavy drinking (WHO criteria)
- •History of stroke
- •History of head trauma
- •Brain metastases known
- •MMS below normal compared to existing standards for age and socio-cultural
结局指标
主要结局
Impact of fatigue, memory problems and attentional
时间窗: up to 12 months after treatment
Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer.
次要结局
- Impact of anxiety and depression(up to 12 months after treatment)
- Effects of different antiangiogenic agents(up to 12 months after treatment)
- List of symptoms(up to 12 months after treatment)
- Impact on the sexuality(up to 12 months after treatment)
- Parameters of quality of life(up to 12 months after treatment)
- disorders of cognitive functions(up to 12 months after treatment)
- biological disturbances(up to 9 months after treatment)
研究者
研究点 (5)
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