NCT02841020撤回不适用
The Effect of Pre-treatment Biopsy for Non-neoplastic Renal Disease vs no Biopsy on Estimated Glomerular Filtration Rate in Patients With Small Renal Mass: a Single-center, Single-blinded, Randomized, Parallel Group Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- difference in change in glomerular filtration rate (GFR)
研究概览
简要总结
The purpose of this study is to determine if biopsy for non-neoplastic renal disease for patients with a small renal mass results in greater postoperative renal function than the current standard of care (no additional biopsy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or greater
- •Scheduled for renal biopsy as part of clinical care
- •Diagnosis of small renal mass (< 4cm) based on imaging (CT, MRI, Ultrasound, or other)
- •Patient must provide written, informed consent for study procedures before randomization
- •Renal mass must be primarily solid (as opposed to cystic) in nature
排除标准
- •Patients less than 18 years of age
- •Patients who are prisoners
- •Women who are pregnant-self reported
- •Patients with Bosniak 3 or 4 cystic renal masses
- •Patients with history of renal transplantation
- •Patients with eGFR less than 30-based on review of clinical labs
- •Patients on dialysis
- •Patients with bleeding disorders
研究组 & 干预措施
Control SOC
No Intervention
Standard of care is followed
Experimental additional biopsy
Experimental
Additional biopsy
干预措施: Additional biopsy (Procedure)
结局指标
主要结局
difference in change in glomerular filtration rate (GFR)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Noah Schenkman, MD
Associate Professor of Urology
University of Virginia
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