Clinical Evaluation of Self-collected Urine Samples for the Detection of Human Papillomavirus in Males
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 12weeks
次要结局
- 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)
研究者
Zhao yongping
Principal Investigator
Peking University People's Hospital