The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.
Study Type
OBSERVATIONAL
Enrollment
1,700
Northwestern Memorial Hospital
Chicago, Illinois, United States
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGThe diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa
The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa. 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 csPCa.
Time frame: The time of prostate biopsy
Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests
The secondary outcome is to evaluate the positive predictive value (PPV), negative predictive value (NPV) and accuracy of exo-RNA panel in detection of csPCa; and compare the diagnostic performance of the plasma-exosome RNA panel with other imaging methods or blood tests in identifying prostate cancer patients; Whether the exo-RNA panel could predict the PCa patients with higher Gleason score (GS). The comparison between diagnostic performance of exo-RNA panel and other imaging or blood tests is performed in ROC curves. The ICC analysis was performed by reliability analysis. All statistical analyses were conducted using IBM SPSS statistics software, version 23.0 (IBM, Inc., Chicago, IL, USA) and GraphPad Prism software, version 8.0 (GraphPad Software, Inc., La Jolla, CA, USA).
Time frame: The time of prostate biopsy
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General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
RECRUITINGWeinan Central Hospital
Weinan, Shaanxi, China
RECRUITINGShaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
RECRUITINGXijing 986 Hospital
Xi'an, Shaanxi, China
RECRUITINGThe Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
RECRUITINGYan'an University Affiliated Hospital
Yan’an, Shaanxi, China
RECRUITINGXijing Hospital
Xi'an, China
RECRUITING