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NCT06671210
Clinical Performance of Urine HPV Testing in Males
trial testing Urine and vaginal swab self-control in HPV in 150 participants. Currently enrolling.
30 March 2025
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 4 November 2024 |
| Primary completion | 30 March 2025 |
| Estimated completion | 30 April 2025 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Urine and vaginal swab self-control
Conditions studied
- HPV — all drugs for HPV →
- Self-sampling — all drugs for Self-sampling →
- Male — all drugs for Male →
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.
Verify or expand the search:
- PubMed search for NCT06671210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06671210 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
- Last refreshed: 5 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06671210.
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