NCT01825005已完成不适用
Predicting Outcome in Cervix Carcinoma: a Prospective Study
Maastricht Radiation Oncology2 个研究点 分布在 2 个国家目标入组 423 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 423
- 试验地点
- 2
- 主要终点
- five-year overall survival rate
研究概览
简要总结
The main aim is to validate and improve the predictive model for survival and toxicity in patients with cervical cancer through multicentric prospective data collection. The data contain information on patient, tumor and treatment characteristics. For this study, additional health related QOL scores will be assessed using the EORTC Quality of Life Questionair-CX24 and C30. The long term aim, beyond this specific study, is to build a Decision Support System based on the predictive model validated in this study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •histological or cytological proven cervical cancer
- •informed consent according to national rules
排除标准
- •no histological or cytological proven cervical cancer
- •no informed consent according to national rules
结局指标
主要结局
five-year overall survival rate
时间窗: 5 years after treatment
assessment of the overall survival 5 years after treatment
次要结局
- three-year distant disease free survival(3 years)
- three-year local disease free survival(3 years)
- five-year distant disease free survival(5 years)
- five-year local disease free survival(5 years)
- number of participants with early adverse events as a measure of safety and tolerability(2 months)
- number of participants with late adverse events as a measure of safety and tolerability(5 years)
研究者
研究点 (2)
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