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NCT06671210

Clinical Performance of Urine HPV Testing in Males

Recruiting now Last updated 5 November 2024
What this trial tests

trial testing Urine and vaginal swab self-control in HPV in 150 participants. Currently enrolling.

Timeline
4 November 2024
Primary endpoint
30 March 2025
30 April 2025

Quick facts

Lead sponsorPeking University People's Hospital
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment150
Start date4 November 2024
Primary completion30 March 2025
Estimated completion30 April 2025
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University People's Hospital

Who can join

18 and older, any sex, with HPV or Self-sampling. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Human papillomavirus (HPV) infection is one of the most prevalent viral infections of the genital tract, primarily transmitted through sexual contact. Research indicates that individuals engaging in sexual activity have a lifetime probability of HPV infection as high as 85% to 90%. While extensive and in-depth investigations have been conducted on HPV infection in women, epidemiological studies focusing on male HPV infection remain relatively scarce. Many men with HPV are asymptomatic; reports suggest that approximately 10.5% of men in China are infected with HPV, yet only about 1% exhibit related symptoms. This substantial population of asymptomatic and unaware patients poses significant challenges for the prevention and control efforts regarding HPV in China. Furthermore, evidence suggests an association between HPV infection and conditions such as condyloma acuminatum, penile intraepithelial neoplasia (PeIN), penile cancer (PA), and even infertility among male patients. In current clinical practice, detection of HPV typically involves collecting exfoliated cells from the external genitalia via swabs. The discomfort associated with this sampling method and its procedural complexity often deter many asymptomatic men from undergoing penile swab testing for HPV, resulting in low compliance rates. Self-sampling urine tests offer advantages including convenience, ease of use, painlessness, and non-invasiveness; thus they may serve as a viable alternative approach. In prior research endeavors, we successfully established a detection system utilizing female urine samples for identifying HPV presence. Consequently, this study aims to further refine this detection system to develop a stable and reliable methodology for detecting HPV using self-collected urine samples from males. Through this investigation not only do we seek to validate the feasibility of employing self-collected urine samples for detecting male HPV infections but also assess the accuracy and practicality of home-based self-testing methods among subjects-ultimately providing novel strategies for male-specific HPV detection

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for HPV

Currently open trials in the same condition.

Other Peking University People's Hospital trials

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Data sources for this page

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