Urine-based Methylation Markers in the Diagnosis and Surveillance of Upper Tract Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Methylation level of urothelial-specific biomarker TRNA-Cys
研究概览
简要总结
This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Pangea Laboratory LLC for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •>=18 years
- •Primary UTUC
排除标准
- •Patients who do not understand and/or are unwilling to sign a written informed consent
研究组 & 干预措施
Patients with primary UTUC (upper tract urothelial carcinoma)
Urine DNA samples will be quantified using Bladder CARE™ at baseline, 3 months, and 6 months.
干预措施: Bladder CARE™ (Diagnostic Test)
结局指标
主要结局
Methylation level of urothelial-specific biomarker TRNA-Cys
时间窗: Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker SIM2
时间窗: Baseline, 3 months, 6 months
Methylation level of urothelial-specific biomarker NKX1-1
时间窗: Baseline, 3 months, 6 months
次要结局
未报告次要终点