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A Prospective, Single-centre，Single-blinded Study of PROUD for Prostate Carcinoma Diagnosis

NCT04699344 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-01-07

No results posted yet for this study

Summary

Prostate carcinoma (PC) is common malignancy and is considered to be the highest incidence in the old males. The traditional diagnostic methods of PC present with some shortcomings. For example, the specificity of serum PSA remains low while prostate needle biopsy is invasive and false negative in some case, even causing missed diagnosis of some high risk PC, and over diagnosis of PC is not rare. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. Our previous study has proved that PROstate cancer Urine Detector (PROUD), which is able to detect chromosomal aberrations of the urine exfoliated cells, is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in PC diagnosis hasn't been assessed yet and the accuracy of PROUD in detecting PC need to be validated. We here intended to investigate whether PROUD can be used in PC diagnosis and further validate the accuracy of PROUD in diagnosing PC.

Conditions

  • Prostate Carcinoma

Interventions

DIAGNOSTIC_TEST

The level of CNV

The extracted DNA from morning urine will be analyzed by PROUD to determine the level of CNV.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Principal Investigators

  • Zunlin Zhou, MD · Qiluhospital of Shandong University

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2023-01-31
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699344 on ClinicalTrials.gov