Clinical Performance of Urine HPV Testing in Males
November 3, 2024 updated by: Zhao yongping, Peking University People's Hospital
Clinical Evaluation of Self-collected Urine Samples for the Detection of Human Papillomavirus in Males
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongping Zhao, Chief physician
- Phone Number: +8601088324516
- Email: zhaoyongping2023@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Peking University People's Hospital
-
Contact:
- Yongping Zhao, PI
- Phone Number: +8601088326666
- Email: zhaoyongping2023@163.com
-
Beijing, Beijing, China, 100000
- Not yet recruiting
- Peking University People's Hospital
-
Contact:
- Yongping Zhao, Professor
- Phone Number: +8601088324516
- Email: zhaoyongping2023@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Self-comparison
|
Each participant provided urine and vaginal swabs for HPV testing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 12weeks
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 8weeks
|
8weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2024
Primary Completion (Estimated)
March 30, 2025
Study Completion (Estimated)
April 30, 2025
Study Registration Dates
First Submitted
October 30, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Actual)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 5, 2024
Last Update Submitted That Met QC Criteria
November 3, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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