Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Tumour progression:
研究概览
简要总结
There is a rising incidence of incidentally detected small renal tumours due to improved imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo surgery and therefore there is limited data about the natural history of these tumours. Several small series have reported that most of these small masses grow slowly and might not require early intervention and that only some masses grow rapidly requiring immediate surgery. Presently, the investigators have not been able to identify prospectively which masses are going to grow slowly. The investigators plan to use computed tomography (CT) and Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to determine which masses will behave more aggressively. Additionally, the observations on the natural history of small renal masses need to be validated with a multicentric and systematically followed cohort.
详细描述
Hypothesis
Since most renal cell carcinomas (RCC's) that are now detected by imaging as small renal masses, grow slowly and remain asymptomatic for years, we hypothesize that:
- Small RCC's that are destined to metastasize do so early or after they reach a larger size
- Delayed surgical treatment of asymptomatic, incidentally detected, small RCC's WILL NOT have a significant impact on overall survival
- The majority of small RCC's MAY NOT need to be treated.
- RCC's that are destined to progress can be identified by abnormal perfusion patterns on imaging and by their cellular and genomic characteristics on needle biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Asymptomatic T1a (< 4.0 cm) renal mass and unfit for surgery due to advanced age or co-morbidity, OR
- •Asymptomatic T1a (< 4.0 cm) and refusal of surgery
- •No evidence of metastatic disease (N0M0)
- •Preparedness to comply with a close follow-up protocol
- •Informed consent
排除标准
- •Life expectancy < 2 years
- •Already being followed for a small renal mass for more than 12 months
- •Concurrent systemic therapy for other malignancies
- •Known hereditary renal cancer syndromes
结局指标
主要结局
Tumour progression:
时间窗: 4 times year 1, 2 times year 2 and 3, yearly thereafter
i) calculated tumour volume doubles (100% increase) within any one-year period, and/or ii) the maximum tumour diameter reaches 4 cm., and/or iii) patients develop symptoms considered to be possibly due to their renal tumour and/or iv) patients develop metastases
次要结局
- Time to Tumour Progression(4 times year 1, 2 times year 2 and 3, yearly thereafter)
- Growth rate(4 times year 1, 2 times year 2 and 3, yearly thereafter)
