The Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Disease-specific survival
研究概览
简要总结
Retrospective studies indicate that active surveillance for clinically localized, small renal masses (cT1a, <=4cm) is safe. It is our hypothesis that active surveillance is safe and efficacious when compared prospectively to patients undergoing immediate intervention for their small renal mass.
详细描述
All patients are offered active surveillance or immediate intervention, as applicable, prior to being offered consent for the DISSRM Registry. All patients are enrolled and followed prospectively. Surveillance patients are followed per protocol with serial imaging, blood work and quality of life questionnaires. Intervention patients are followed at the discretion of the attending surgeon with serial QOL appointments/questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a solid, enhancing renal mass ≤4cm at its greatest dimension found on incidental scanning in the last 6 months.
- •Age ≥ 18 and able to read, understand and sign informed consent.
- •Must be willing to adhere to the treatment algorithm and time constraints therein.
排除标准
- •Cannot have suspicion of metastases to the kidney if any other malignancy diagnosed within two years of study entry.
研究组 & 干预措施
Crossover (Delayed Intervention)
Initially patients in active surveillance that meet progression criteria or elect to undergo delayed intervention.
Active Surveillance
Immediate Intervention
May include patients undergoing open or minimally-invasive partial nephrectomy, radical nephrectomy or energy ablation.
结局指标
主要结局
Disease-specific survival
时间窗: 5 years
Safety and Efficacy of active surveillance and delayed intervention for the SRM, measured by disease-free survival at 5-years.
次要结局
- Objective Safety and Tolerability of Percutaneous Renal Biopsy(5 years)
- Quality-of-life outcomes for patients undergoing AS versus definitive therapy.(5 years)
- To determine objective selection criteria for active surveillance.(5 years)