PROspective Renal Cancer Cohort (PRO-RCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 26
- 主要终点
- progression
研究概览
简要总结
PRO-RCC is a nationwide long-term cohort for the collection of real-world clinical data, patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) that provides an infrastructure for observational research and (randomized) interventional studies with the TwiCs (Trial within cohorts) design.
详细描述
PRO-RCC is designed as a multicenter cohort for all Dutch patients with localized RCC or metastatic renal cell carcinoma (mRCC). The clinical data collection is embedded in the framework of the Netherlands Cancer Registry (NCR). Next to the standardly available data on RCC, additional clinical data will be collected. The informed consent for PRO-RCC covers the online collection of PROMs and PREMS, data sharing and data linking with the NCR. PROMS entail Health-Related Quality of Life (HRQoL), and optional return to work- questionnaires. PREMS entail satisfaction with care. Both PROMS and PREMS are collected through the PROFILES registry and are accessible for the patient and the treating physician. Importantly, participants may also consent to participation in a 'Trial within cohort' studies (TwiC). The TwiC design provides a method to perform (randomized) studies within the registry.
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
- •newly diagnosed patients with RCC or synchronous metastatic RCC
- •metachronous metastasized RCC
- •age >18 years
- •capable of understanding Dutch language
排除标准
- 未提供
结局指标
主要结局
progression
时间窗: 5 years
local or distant recurrence
patient reported outcome measures (PROMS)
时间窗: 5 years
measured with the EORTC QLQ-C30 questionnaire, every three months in the first year, then yearly up to five years.
survival
时间窗: 5 years
overall survival
次要结局
- Patient reported outcomes of adverse events(2 years)