Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,170
- 试验地点
- 1
- 主要终点
- Diagnostic Performance for the detection of urothelial carcinoma
研究概览
简要总结
Clinical trial to evaluate the performance characteristics(sensitivity and specificity) of AnchorDx's urine DNA methylation/somatic mutation profiling assay for detecting urothelial carcinoma compared to pathology in patients.
详细描述
This is a prospective study that involves 11 centers in China and 1200 participants. The assay analyzes the DNA methylation/somatic mutation profiles of bladder cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The performance characteristics(sensitivity and specificity) of the assay for detection of 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
- 是
入选标准
- •Urothelial carcinoma group:
- •Any male or female patient aged 18 or older.
- •Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •Diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgery.
- •interference group:
- •Any male or female patient aged 18 or older.
- •Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •Diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery.
- •Control group:
- •Any male or female patient aged 18 or older.
- •Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •Diagnosed with urinary disease such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis. All enrollee are able to provide legally effective informed consent.
- •Healthy volunteers group:
- •Any male or female patient aged 18 or older.
- •Able to provide urine specimen (100ml for both first void and non-first-void urine) before physical examination.
- •exclusion criteria:
- •Urothelial carcinoma/Interference group/Control group
- •Has had diagnosed with other cancers.
- •Patients diagnosed with non-urological cancer.
- •Failed to provide a written informed consent.
- •Healthy volunteers group:
- •Volunteers with abnormal test results of urine analysis or urological ultrasound test.
- •Volunteers sceptical of cancers from non-urological origin in a normal results of urine analysis or urological ultrasound.
- •Failed to provide legally effective informed consent.
排除标准
- 未提供
结局指标
主要结局
Diagnostic Performance for the detection of urothelial carcinoma
时间窗: 1 Years
The efficacy of the urine DNA methylation/somatic mutation profiling assay for the detection of urothelial carcinoma comparing with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and accuracy.
次要结局
- Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma(1 Years)