Effect of Male Circumcision on Penile HPV Infection

男性包皮环切术对阴茎 HPV 感染的影响

• 批准号: 7121613
• 负责人: JENNIFER SUSAN SMITH
• 金额: $ 43.89万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-12 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7121613
• 关键词: adolescence (12-20); cancer prevention; cervix neoplasms; clinical research; clinical trials; communicable disease control; endoscopy; histopathology; human papillomavirus; human subject; human therapy evaluation; male; male reproductive system surgery; penis; polymerase chain reaction; sex partner; sexually transmitted diseases; virus diseases; virus related neoplasm /cancer; young adult human (21-34)

DESCRIPTION (provided by applicant): Human papillomavirus (HPV) is the central cause of invasive cervical cancer (ICC) in women, and other anogenital cancers, including anal, penile, vaginal and vulvar cancers. Public health intervention strategies are needed to reduce the genital acquisition of high-risk HPV types to prevent these cancers that affect women and men. Given that men are important in transmitting HPV to their female sexual partners, interventions that reduce HPV acquisition and persistence in men could be an important HPV prevention strategy benefiting both men and women. Limited cross-sectional data suggest that male circumcision may reduce the carriage of penile HPV infection. However, proof that male circumcision reduces HPV penile infection acquisition and/or persistence can only be obtained through the conduct of a prospective, randomized clinical trial (RCT). The University of North Carolina, in collaboration with the UNIM (Universities of Nairobi, Illinois and Manitoba Reproductive Health Project) Male Health Clinic, The University of Illinois at Chicago, the University of Nairobi, the Albert Einstein College of Medicine in New York City, and the Vrije Universiteit Medical Center in Amsterdam proposes to study of the effect of male circumcision on the risk and natural history of penile HPV infection in young, sexually active men in Kisumu, Kenya. This proposed study of penile HPV infection is nested within an ongoing "parent" RCT to assess the effect of male circumcision in reducing HIV incidence in 18-24 year-old men in Kisumu that began in February 2002. This HPV project proposes to determine the type-specific HPV DNA prevalence in penile exfoliated cell samples currently being collected as part of the ongoing RCT of male circumcision. An estimated 2,442 men are expected to contribute penile exfoliated cell specimens from two anatomical sites (the shaft and glans/coronal sulcus). These sample are being collected at enrollment and at the 6-, 12-, 18- and 24- month follow-up visits. Specimens will be tested using a sensitive PCR assay to detect a wide-range of HPV DNA types. HPV viral load of samples positive for HPV types 16, 18, 31, 33 and 45 will be determined using a real-time PCR. A new clinical examination (a visual inspection with 3% acetic acid and aided magnification) will be added to this ongoing RCT at the final 24-month visit to determine the presence of penile lesions (i.e., flat lesions, papular lesions, or condolymata acuminate). Study results will provide the most definitive evidence to date regarding the effect of male circumcision on HPV infection and penile lesions in men. If male circumcision is found to be effective and safe in reducing HPV infection or penile lesions in men, it could in turn reduce HPV prevalence and associated cervical neoplasia in women.

描述（由申请人提供）：人乳头瘤病毒（HPV）是女性侵入性宫颈癌（ICC）的核心原因，以及其他肛门生殖器癌，包括肛门，阴茎，阴道和外阴癌。需要采取公共卫生干预策略来减少高风险HPV类型的生殖器获取，以防止这些影响男女的癌症。鉴于男性在将HPV传输给其女性性伴侣方面很重要，因此减少HPV获取和持久性的干预措施可能是对男性和女人都受益的HPV预防策略。有限的横截面数据表明，男性包皮环切术可以减少阴茎HPV感染的运输。但是，只有通过进行前瞻性，随机临床试验（RCT）来获得雄性包皮环切术可减少HPV阴茎感染的获取和/或持久性的证据。 The University of North Carolina, in collaboration with the UNIM (Universities of Nairobi, Illinois and Manitoba Reproductive Health Project) Male Health Clinic, The University of Illinois at Chicago, the University of Nairobi, the Albert Einstein College of Medicine in New York City, and the Vrije Universiteit Medical Center in Amsterdam proposes to study of the effect of male circumcision on the risk and natural history of penile HPV肯尼亚基苏木的年轻，性活跃男人感染。这项提出的对阴茎HPV感染的研究嵌套在正在进行的“父” RCT中，以评估男性包皮环切术在2002年2月开始的Kisumu 18-24岁男性中降低艾滋病毒发病率的影响。 该HPV项目提议确定当前在持续的男性包皮环切术的一部分的阴茎去角质细胞样品中的类型特异性HPV DNA患病率。估计有2,442名男性有望从两个解剖部位（轴和龟头/冠状沟）贡献阴茎去角质的细胞样本。这些样本在入学时以及6个，12个，18个月和24个月的随访访问中收集。标本将使用敏感的PCR分析进行测试，以检测广泛的HPV DNA类型。将使用实时PCR确定HPV样品的HPV病毒载荷样品阳性的16、18、31、33和45。将在最后24个月的访问中添加新的临床检查（具有3％乙酸和辅助放大倍率的视觉检查），以确定阴茎病变的存在（即扁平病变，丘疹病变或辅助症状）。 研究结果将为迄今为止关于男性包皮环切术对HPV感染和男性阴茎病变的影响提供最确定的证据。如果发现男性包皮环切术在减少男性的HPV感染或阴茎病变方面有效且安全，则可能会降低女性的HPV患病率和相关的宫颈肿瘤。