Evaluating urine HPV testing in men
Clinical Evaluation of Self-collected Urine Samples for the Detection of Human Papillomavirus in Males
This study is testing if urine samples can effectively detect HPV in men with genital warts or penile issues compared to samples collected by doctors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06671210 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of urine samples for detecting HPV in males compared to traditional physician-collected samples. It involves male patients with genital warts, penile intraepithelial neoplasia, and penile cancer, who will self-collect urine samples followed by physician-collected samples for comparison. Additionally, the study examines the consistency of HPV infection between male patients and their female partners through urine and cervical swabs. The goal is to enhance understanding of HPV prevalence and improve detection methods in males.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older who have had sexual experience and are in long-term, unprotected relationships.
Not a fit: Patients who are not sexually active or those who cannot provide valid samples due to technical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accessible and effective HPV screening methods for men, potentially reducing the incidence of HPV-related conditions.
How similar studies have performed: While there is limited research on male HPV infection, similar studies in female populations have shown success in using self-collected samples for HPV detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be at least 18 years old and have had sexual experience; * After one year or more of regular, unprotected sexual activity without pregnancy in married couples； ③Voluntarily participate in this study after communication and sign an informed consent form. Exclusion Criteria: * Samples that cannot obtain valid nucleic acid test results, including but not limited to samples with human errors in clinical trial testing process or samples with insufficient volume to complete a valid test; ② Incomplete demographic information and laboratory test related information of the subjects.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yongping Zhao, Chief physician
- Email: zhaoyongping2023@163.com
- Phone: +8601088324516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.