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

在世纪，利率在过去二十年中保持稳定。尽管有高度敏感的筛查方法，如人乳头瘤病毒（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名妇女死于宫颈癌。在所有宫颈癌新发病例中，有一半以上是从未接受过筛查或很少接受筛查的妇女，这反映出由于地理位置偏远而造成的巨大社会经济差距和障碍。正在评估的克服这些障碍的另一种筛查方法是妇女自己采集样本（“自我采样”），并将样本送去进行HPV检测。这种方法提供了几个好处，包括在妇女选择的时间/地点容易收集，而不需要诊所预约或窥器检查。这种干预措施具有很大的潜力，可以将宫颈癌筛查扩大到从未筛查或筛查不足的妇女，并解决缺乏筛查作为健康差距的紧迫公共卫生问题。 国家癌症研究所（NCI）制定了宫颈癌“最后一英里”倡议，作为几个利益相关者之间的公私伙伴关系（包括联邦机构、行业合作伙伴和专业协会/临床实践指南组织），以验证基于自我采样的HPV检测作为一种可比较的在宫颈癌筛查中，作为提供者采集的宫颈标本用于HPV检测的（非劣效）替代方案，并促进监管批准和在真实的世界实践环境中更广泛地采用这种方法。为了实现这一目标，NCI将支持一项全国性的多中心筛查试验，即在不同分娩环境中进行的“自我采样进行HPV检测以改善宫颈癌预防”试验（SHIP试验）。在与美国食品药品监督管理局（FDA）和行业合作伙伴进行讨论之前，SHIP试验可设计为批准前试验或批准后试验，具体取决于批准的监管途径。本文件假设了批准后试验的研究设计

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