Plasma Exosome RNA to Diagnose Prostate Cancer

N/AEnrolling By InvitationNCT06604130

Xijing Hospital1,600 enrolled

Overview

The aim of the present study is to investigate a RNA combination to diagnose prostate cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,600

Conditions

Prostate Cancer

Interventions

Prostate cancer screening decisionDIAGNOSTIC_TEST

The subjects would receive serum PSA test.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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, and PSMA PET/CT examination. 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

Locations (9)

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Weinan Central Hospital

Outcomes

Primary Outcomes

The diagnostic efficacy of plasma exo-RNA panel alone in diagnosing PCa

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.

Time frame: The time of prostate biopsy and after 6 months follow-up

Secondary Outcomes

Diagnostic efficacy of plasma exo-RNA panel in diagnosing csPCa, insignPCa 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 PCa; to evaluate the perforamce of exo-RNA panel in identifying grade group 2 (GG2) or higher clinically significant prostate cancer (csPCa) tumors 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 and after 6 months follow-up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.