Study of Minimally-invasive Ablative Renal Therapies (SMART) Registry
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- kidney cancer disease-specific survival
研究概览
简要总结
Multi-center prospective cohort study examining curative intent renal cryotherapy and radiofrequency ablation for small renal mass treatment in patients who are poor candidates for surgical resection, We will capture clinical, radiological, and pathological data as well as resource utilization (ex: time in hospital, ER visits), complications, and long-term functional and oncological outcomes. The investigators will also be biobanking blood and urine samples from participants for biological studies in the lab.
详细描述
Currently the standard-of-care for non-operative renal masses which require treatment is curative ablative therapy. Curative ablative therapies include radiofrequency ablation (RFA) and cryotherapy. A significant number of patients (approximately 40-50%) can only be treated with cryotherapy rather than RFA because of the target lesions close proximity to the collecting system, ureter, solid organs or hollow viscera. Cryotherapy allows for size control of the ablation zone with CT surveillance to avoid iatrogenic injury to these vital structures. On the other hand RFA does not allow for the same ability to control the size of ablation and, unfortunately due to the thermal energy, can result in injury to these structure precluding the use of RFA as a curative therapy for these patients.
Cryoablation of small renal masses provides equivalent intermediate-term cancer control compared to partial nephrectomy. Three-year local recurrence-free survival is 98% for both cryoablation and partial nephrectomy. Similarly metastasis-free survival three years after treatment is 100% for cryoablation and 99% for partial nephrectomy. Curative renal mass ablations provide the added benefit of being outpatient procedures which do not routinely require more than a 4 hour post-procedural recovery and over-the-counter post-procedural analgesic.
Research Question and Objectives:
The objective is to to provide cryotherapy and RFA as curative treatment options for small renal mass treatment in patients who are poor candidates for surgical resection or for those who are not surgical candidates due to co-morbidities. The investigators aim to establish a database that prospectively captures clinical, radiological, and pathological data as well as resource utilization (ex: time in hospital, ER visits), complications, and long-term functional and oncological outcomes. The study will also be biobanking blood and urine samples from participants for biological studies in the lab.
Methods:
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
- •Adults with prior kidney tumor diagnosis;
- •Willing to permit provincial agencies (e.g Alberta Health Services, Alberta Health, Netcare, Service Alberta) to disclose health-related information to study;
- •Canadian and Albertan residents;
- •Signed informed consent.
排除标准
- •Unwilling to participate in the study;
- •Unavailable for standard clinical urological care or follow-up in Alberta
结局指标
主要结局
kidney cancer disease-specific survival
时间窗: 5 years
次要结局
- Overall survival(5 years)
- Glomerular Filtration Rate GFR (mL/min/1.73m2)(5 years)
- Serum Creatinine (umol/L)(5 years)
- Progression-free survival(5 years)