Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 主要终点
- Sensitivity
研究概览
简要总结
Metabolomics is a complementary approach for identifying perturbed metabolic pathways. The goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics.
详细描述
Early diagnosis and life-long surveillance are clinically important to improve the long-term survival of bladder cancer patients. Currently, a noninvasive biomarker that is as sensitive and specific as cystoscopy in detecting bladder cancer is lacking. Metabolomics are small organic molecules (below 2000 mass units) that are products of complex pathways. This is a prospective study aims to create an early diagnostic model based on serum and urine metabolomics. Commonly employed metabolomics analytical platforms include nuclear magnetic resonance spectroscopy (NMR), gas chromatography mass spectrometry (GC-MS), and liquid chromatography mass spectrometry （LC-MS）. The diagnostic model will be made to distinguish bladder cancer and benign disease of the urinary system.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bladder cancer group:
- •Any male or female patient aged 18 or older
- •Able to provide serum and urine specimen before treatment
- •Diagnosis with incident or recurrent bladder cancer
- •Control group
- •Any male or female patient aged 18 or older
- •Able to provide serum and urine specimen before treatment
- •Diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia.
排除标准
- •Kidney and liver dysfunction.
- •Incomplete clinical information and laboratory test result
- •Tumor-related treatment was received preoperatively
- •Preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors
结局指标
主要结局
Sensitivity
时间窗: 1 year
Measurement the sensitivity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
Specificity
时间窗: 1 year
Measurement the specificity of diagnostic model based on urine and serum metabolomics in differentiating between bladder cancer and benign disease of the urinary system
次要结局
未报告次要终点