Plasma Exosome RNA to Diagnose Prostate Cancer

NCT ID: NCT06604130

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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The experimental arm receiving diagnosis from serum RNA combination

Group Type EXPERIMENTAL

Prostate cancer screening decision

Intervention Type DIAGNOSTIC_TEST

The subjects would receive serum PSA test.

Interventions

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Prostate cancer screening decision

The subjects would receive serum PSA test.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

Yan'an University Affiliated Hospital

OTHER

Sponsor Role collaborator

Weinan Central Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Affiliated Hospital of Qinghai University

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Air Force 986 Hospital

UNKNOWN

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Qinghai University Affiliated Hospital

Xining, Qinghai, China

Site Status

Weinan Central Hospital

Weinan, Shaanxi, China

Site Status

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Site Status

Xijing 986 Hospital

Xi'an, Shaanxi, China

Site Status

Xijing Hospital

Xi'an, Shaanxi, China

Site Status

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, China

Site Status

Affiliated Hospital of Yan'an University,

Yan’an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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NSFC(China)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KY20242271-C-1

Identifier Type: -

Identifier Source: org_study_id

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