NCT07492927 · Xijing Hospital
Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer
What this study is about
The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.
View original scientific description
The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.
Primary outcome measures
The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing csPCa
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Blood prostate-specific antigen PSA\>4ng/dl;
- Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging.
- The patient is willing to undergo prostate biopsy.
Exclusion criteria
- 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
Where
- Chicago, Illinois
Collaborators
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
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations