Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Efficacy of urine DNA methylation/somatic mutation test
研究概览
简要总结
Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.
详细描述
This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.
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
- •Case group:
- •1.Any male or female patient aged 18 or older.
- •2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
- •4.Able to provide legally effective informed consent.
- •Control group:
- •1.Any male or female patient aged 18 or older.
- •2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •3.Diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis.
- •4.Able to provide legally effective informed consent.
排除标准
- •1.Patients had been diagnosed with cancer history.
- •2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
结局指标
主要结局
Efficacy of urine DNA methylation/somatic mutation test
时间窗: 1 Year
Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)
次要结局
未报告次要终点