Clinically Significant Prostate Cancer
Conditions
Brief summary
The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.
Interventions
None listed
Sponsors
Xijing Hospital
Shaanxi Provincial People's Hospital
Weinan Central Hospital
Shaanxi University of Chinese Medicine
LanZhou University
Qinghai University
Ningxia Medical University
Northwestern University
Yan'an University Affiliated Hospital
Air Force Military Medical University, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Blood prostate-specific antigen PSA\>4ng/dl; 2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging. 3. The patient is willing to undergo prostate biopsy.
Exclusion criteria
1. Previous diagnosis of prostate cancer through prostate biopsy; 2. History of other malignant tumors in the past two years; 3. According to the research physician''s judgment, serious complications may occur and affect the normal conduct of the experiment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa | The time of prostate biopsy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests | The time of prostate biopsy | 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). |
Countries
China, United States
Contacts
CONTACTJianhua Jiao, MD.
STUDY_CHAIRWeijun Qin, MD.
Xijing Hospital
Outcome results
None listed