PROGRESS: PRevention of cervical cancer using the Genotyping scREening and Same-day Self-sampling

进展：利用基因分型筛查和当天自我采样预防宫颈癌

• 批准号: 10491481
• 负责人: Miriam Cremer
• 金额: $ 101.13万
• 依托单位: ATILA BIOSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-05 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10491481
• 关键词: Ablation; Acetic Acids; Address; Age; Artificial Intelligence; Biopsy; Bypass; Caring; Categories; Cellular Phone; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Cervix Uteri; Characteristics; Clinical; Collection; Colposcopy; Cytology; DNA; Data; Detection; Development; Disease; Disease Progression; Disease model; Eligibility Determination; Evaluation; Female Adolescents; Genotype; Goals; HPV-High Risk; Health; Health Planning Organizations; High Risk Woman; Honduras; Hour; Human Papillomavirus; Human papilloma virus infection; Image; Incidence; Laboratories; Lesion; Low income; Malignant neoplasm of cervix uteri; Mediating; Methods; Modality; Modeling; Oncogenic; Patients; Pelvic Examination; Performance; Point of Care Technology; Predictive Value; Prevalence; Process; Provider; Reporting; Resource-limited setting; Resources; Risk; Sampling; Screening Result; Technology; Testing; TimeLine; Triage; Unnecessary Procedures; Ursidae Family; Vaccinated; Vaccination; Visit; Visual; Woman; World Health Organization; acceptability and feasibility; automated visual evaluation; base; cervical cancer prevention; commercialization; cost; cost effective; cost-effectiveness evaluation; cost-effectiveness ratio; design; digital imaging; follow-up; high risk; incremental cost-effectiveness; innovation; isothermal amplification; low and middle-income countries; member; mortality; overtreatment; performance tests; premalignant; screening; secondary analysis; treatment duration

PROJECT SUMMARY In 2018, the World Health Organization (WHO) called for action towards achieving the global elimination of cervical cancer. Member states ratified a strategy for achieving this goal in August 2020. The WHO plan calls for an aggressive approach of vaccination, screening, and treatment of the human papillomavirus (HPV), the single cause of cervical cancer. In low- and middle-income countries (LMIC), which bear 90% of the incidence and mortality of cervical cancer globally, it is estimated that these goals will not be reached until 2120 – a century from now. One way to shorten this timeline is through HPV self-sampling and immediate treatment for those at the highest risk of developing invasive disease. This will only be possible through a low-cost and effective test that is easy to use in the field, combined with triage strategies that channel women to treatment but avoid unnecessary procedures that drain limited resources. The modified AmpFire® HPV Genotyping test (Atila Biosystems, CA) is a new test that identifies 13 high-risk HPV types and stratifies them by oncogenic risk into four groups. AmpFire® relies on loop-mediated isothermal amplification (LAMP) rather than DNA extraction, thus allowing for small-batch processing in 1-2 hours at a low cost per sample. No other HPV test has these characteristics, which allow for the development of same-day screen-and-treat strategies that can triage women at the highest risk, reduce loss to follow-up, and decrease overtreatment. Furthermore, the modified AmpFire® has demonstrated high sensitivity in self-collected samples. The purpose of this study is to evaluate the performance of this in the detection of high-grade precancer (cervical intraepithelial neoplasia, grade 2 or higher, or CIN2+). We will also pilot a same-day screen-and-treat strategy using AmpFire® and Automated Visual Assessment (AVE), an artificial intelligence triage method based on an assessment of cervical images captured with an ordinary smartphone. Thus, this study will accomplish the following Specific Aims: Specific Aim 1: To estimate the test performance of self- and provider- collected modified AmpFire® screening platform in Honduras; Specific Aim 2: To evaluate the feasibility of a single visit approach using a self-sampled modified AmpFire® screening platform; Specific Aim 3: Evaluate the cost-effectiveness of the same-day screen-and-treat approach using the modified AmpFire® test followed by triage with Automated Visual Evaluation (AVE) versus the current strategy in Honduras.

项目概要 2018年，世界卫生组织（WHO）呼吁采取行动，实现全球消除 会员国于 2020 年 8 月批准了实现这一目标的战略。世卫组织计划呼吁 对于人乳头瘤病毒 (HPV) 的积极疫苗接种、筛查和治疗方法， 在低收入和中等收入国家（LMIC），宫颈癌的发病率高达 90%。 和全球宫颈癌死亡率，估计这些目标要到 2120 年才能实现 – 一个世纪后，缩短这一时间的一种方法是通过 HPV 自我采样和立即治疗。 那些患侵袭性疾病的风险最高的人这只能通过以下方法实现。 低成本、有效的测试，易于在现场使用，并结合引导女性的分流策略 进行治疗，但避免不必要的程序，这些程序会耗尽有限的资源。 基因分型测试（Atila Biosystems，加利福尼亚州）是一种新测试，可识别 13 种高危 HPV 类型并对它们进行分层 AmpFire® 按致癌风险分为四组，而依赖于环介导等温扩增 (LAMP)。 比 DNA 提取更方便，因此可以在 1-2 小时内以较低的成本对每个样品进行小批量处理。 HPV 检测具有这些特征，可以制定当天筛查和治疗策略 这可以对风险最高的女性进行分类，减少随访损失，并减少过度治疗。 改良的 AmpFire® 在自行采集的样本中表现出高灵敏度。本研究的目的是。 评估其在检测高级别癌前病变（宫颈上皮内瘤变、 2 级或更高级别，或 CIN2+）我们还将使用 AmpFire® 试行当天筛查和治疗策略 自动视觉评估（AVE），一种基于评估的人工智能分类方法 因此，本研究将完成以下具体任务。 目标： 具体目标 1：评估自行收集和提供者收集的修改后的测试性能 洪都拉斯的 AmpFire® 筛查平台；具体目标 2：评估单次访问的可行性 使用自采样改进的 AmpFire® 筛选平台的方法；具体目标 3：评估 使用改进的 AmpFire® 测试的当天筛查和治疗方法的成本效益 然后使用自动视觉评估 (AVE) 与洪都拉斯当前策略进行分类。