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RecruitingObservational

Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer

NCT ID: NCT07492927Sponsor: Xijing HospitalLast updated: 2026-03-25

Summary

The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.

Arms & interventions

Outcome measures

Primary

  • The 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

Secondary

  • Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa and its comparison with other imaging methods or blood tests

    Time frame: The time of prostate biopsy

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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

Study locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611

Recruiting
Qiang Zhang, MD. · Contact
Qiang Zhang, MD. · Principal Investigator
Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer | Cancerify