COORDINATING CENTER FOR THE NCI CERVICAL CANCER LAST MILE INITIATIVE SELF-SAMPLING FOR HPV TESTING TO IMPROVE CERVICAL CANCER PREVENTI

在二十世纪，在过去的二十年里，利率已经趋于平稳。尽管有高度敏感的筛查方法，如人类乳头瘤病毒（HPV）检测，但在美国，每年仍有超过13,000名妇女被诊断患有宫颈癌，超过4,000名妇女继续死于宫颈癌。在所有新发宫颈癌病例中，一半以上的妇女要么从未接受过筛查，要么很少接受筛查，这反映出由于地理位置上的不便，存在巨大的社会经济差异和障碍。为了克服这些障碍，正在评估的另一种筛查方法是妇女自己自行收集样本（“自我抽样”）并将样本送去进行HPV检测。这种方法有几个好处，包括方便在妇女选择的时间/地点收集，而不需要门诊预约或镜检查。这一干预措施具有很大的潜力，可以将宫颈癌筛查扩大到从未接受过筛查或未接受过筛查的妇女，并解决缺乏接受筛查的机会这一紧迫的公共卫生问题，这是一种健康差距。

the twentieth century, rates have plateaued for the past two decades. Despite the availability of highly sensitive screening methods such as human papillomavirus (HPV) testing, over 13,000 women continue to be diagnosed with and over 4,000 women continue to die of cervical cancer annually in the US. Over half of all new cervical cancer cases are among women who have either never been screened or who have been infrequently screened, reflecting substantial socio-economic disparities and barriers due to geographic inaccessibility. An alternative screening approach under evaluation to overcome these barriers is self-collection of samples (‘self-sampling’) by women themselves and sending the sample for HPV testing. This approach offers several benefits including ease of collection at a time/place of women’s choice without a need for a clinic appointment or a speculum examination. This intervention has significant potential to expand cervical cancer screening to never screened or under-screened women and address a pressing public health concern of lack of access to screening as a health disparity. The National Cancer Institute (NCI) has developed the Cervical Cancer ‘Last Mile’ Initiative as a public private partnership between several stakeholders (including federal agencies, industry partners, and professional societies/clinical practice guidelines organizations) to validate self-sampling-based HPV testing as a comparable (non-inferior) alternative to provider-collected cervical specimen for HPV testing in cervical cancer screening, and facilitate regulatory approvals and broader adoption of this approach in real world practice settings. Towards this goal, the NCI will support a nationwide, multicentric screening trial, the Self-sampling for HPV testing to Improve Cervical Cancer Prevention (SHIP)” Trial (‘SHIP Trial’) in diverse delivery settings. Pending discussions with the US Food and Drug Administration (FDA) and the industry partners, the SHIP Trial may be designed as a pre-approval trial or a post-approval trial, dependent on the approved regulatory pathways. This document assumes a study design of a post-approval trial