Clinical trial NCT06671210: Clinical Performance of Urine HPV Testing in Males
Official title: Clinical Evaluation of Self-collected Urine Samples for the Detection of Human Papillomavirus in Males
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV
Self-sampling
Male
Keywords: urine
HPV
male
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Hangzhou Newhorizon Health Technology Co., Ltd.
First posted: 2024-11-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Detailed description: The first part of the study aims to investigate the consistency of HPV infection between self-collected urine samples and physician-collected penile samples in male patients with genital warts, PIN and PA. Eligible subjects were enrolled, and they were first asked to collect 20-30 ml of urine by themselves, followed by physicians collecting urine samples from the urethral orifice, the surface of the external genitalia, and the surface (if any) of the lesion using urine self-collection swabs to compare the consistency of HPV infection between the two sample types. The second part of the study aims to investigate the consistency of HPV infection between urine samples of male patients and their female partners. Eligible subjects and their female partners were enrolled, and they were first asked to collect the urine sample by themselves. Urine samples were then collected from the urethral orifice and the surface of the external genitalia of the male partner by physicians using urine self-collection swabs, and a cervical swab was taken from the surface of the cervix of the female partner to compare the consistency of HPV infection between the two partners and the consistency of HPV infection between the two sample types.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12weeks
Secondary outcomes:
measure: 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.
timeFrame: 8weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
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citation: 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.
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citation: 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.