Investigation of Urine Volatile Organic Compounds as Novel Diagnostic Biomarker in Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Urine volatile organic compounds composition of all urine samples
研究概览
简要总结
The goal of this study to investigate the volatile organic compounds (VOCs) in the urine samples of both healthy individual and bladder cancer patients, using gas chromatography - mass spectrometry. Researchers aim to find a set of certain VOCs specific to bladder cancer and use this set to construct a diagnostic model that can help diagnosing bladder cancer. Participants will be asked to collect their early morning midstream urine in a predesignated container. Researchers will compare urine VOCs from bladder cancer patients and healthy individuals to see if there is any VOC whose concentration differ significantly among the two groups.
详细描述
Specifically, participants will be asked to collect 35-45 ml of their early morning midstream urine sample in a predesignated polytetrafluoroethylene bottle. Researcher will collect participants' health information, including their: 1)smoking history; 2)comorbidity; 3) history of past urological procedure; 4)medication; 5)pathology diagnosis after surgery, if participants have bladder cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •bladder tumor confirmed by cystoscopy and radiology
- •women of childbearing age with negative urine pregnancy test result
- •willing to participate in this trial and sign the informed consent form
排除标准
- •patient with 1) uncontrollable urinary tract infection; 2) severe systemic disease; 3) history of malignancy within the past 5 years; 4) pregnancy or lactation
- •patient involved in other clinical trials
- •other situations researcher considered to be ineligible for this trial
结局指标
主要结局
Urine volatile organic compounds composition of all urine samples
时间窗: immediately after GC-MS analysis has been finished
Data derived from mass spectrums of GC-MS measurement of VOC components in urine samples, including VOC components identified comparing obtained data to those in public GC-MS database and the absolute concentration of VOCs identified.
次要结局
- Pathological diagnosis of bladder tumor patients enrolled(Immediately after the release of pathological examination reports by pathology department in the First affiliated hospital of Xi'an jiaotong university)