Plasma Exosome RNA Combination for Diagnosing Prostate Cancer: a Prospective, Multicenter Diagnostic Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,600
- 试验地点
- 9
- 主要终点
- The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa
研究概览
简要总结
The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Blood prostate-specific antigen PSA>4ng/dl;
- •Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging, and PSMA PET/CT examination.
- •The patient is willing to undergo prostate biopsy.
排除标准
- •Previous diagnosis of prostate cancer through prostate biopsy;
- •History of other malignant tumors in the past two years;
- •According to the research physician's judgment, serious complications may occur and affect the normal conduct of the experiment
研究组 & 干预措施
The experimental arm receiving diagnosis from serum RNA combination
干预措施: Prostate cancer screening decision (Diagnostic Test)
结局指标
主要结局
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa
时间窗: The time of prostate biopsy and after 6 months follow-up
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing prostate cancer and evaluate its sensitivity and specificity in diagnosing PCa. Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with PCa.
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa
时间窗: The time of prostate biopsy and after 6 months follow-up
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing prostate cancer and evaluate its sensitivity and specificity in diagnosing PCa. Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with PCa.
次要结局
- Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests(The time of prostate biopsy and after 6 months follow-up)
- Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa and its comparison with other imaging methods or blood tests(The time of prostate biopsy and after 6 months follow-up)