Clinical Performance of Urine HPV Testing in Males

NCT06671210 | Recruiting DMC

• 1 other identifier: 2024PHB118-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HPV; Self-sampling; Male

Keywords

urine; HPV; male

Outcome Measures

Primary Outcomes (1)

• Compare the test results of the candidate reagent for HPV detection on appropriate urine samples from the same male subject with the results of the marketed HPV nucleic acid detection products on external genital samples of the subject.

  12weeks

Secondary Outcomes (1)

• Compare the consistency of HPV nucleic acid in urine samples of male subjects and their spouses to explore the feasibility of using the under-evaluation reagent for couples' joint testing with suitable urine samples.

  8weeks

Study Arms (1)

Self-comparison

Device: Urine and vaginal swab self-control

Interventions

Urine and vaginal swab self-control DEVICE

Each participant provided urine and vaginal swabs for HPV testing.

Self-comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men who meet the inclusion criteria, or infertile couples, who are willing to participate in a clinical trial and seek treatment at the Dermatology and Reproductive Medicine Department of Peking University People's Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Hangzhou Newhorizon Health Technology Co., Ltd.: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (4)

• Garland SM, Kjaer SK, Munoz N, Block SL, Brown DR, DiNubile MJ, Lindsay BR, Kuter BJ, Perez G, Dominiak-Felden G, Saah AJ, Drury R, Das R, Velicer C. Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of 10 Years of Real-world Experience. Clin Infect Dis. 2016 Aug 15;63(4):519-27. doi: 10.1093/cid/ciw354. Epub 2016 May 26.

  PMID: 27230391 BACKGROUND

• Smits PH, Bakker R, Jong E, Mulder JW, Meenhorst PL, Kleter B, van Doorn LJ, Quint WG. High prevalence of human papillomavirus infections in urine samples from human immunodeficiency virus-infected men. J Clin Microbiol. 2005 Dec;43(12):5936-9. doi: 10.1128/JCM.43.12.5936-5939.2005.

  PMID: 16333078 BACKGROUND

• Wu H, Tong X, Wang L, Huang Y, Zhang L. HPV vaccine information, knowledge, attitude, and recommendation intention among male college students in China. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228163. doi: 10.1080/21645515.2023.2228163.

  PMID: 37389484 BACKGROUND

• Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014 Nov;41(11):660-4. doi: 10.1097/OLQ.0000000000000193.

  PMID: 25299412 BACKGROUND

Central Study Contacts

Yongping Zhao, Chief physician

CONTACT

+8601088324516; zhaoyongping2023@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: November 4, 2024
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)