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: 10696230
• 负责人: Miriam Cremer
• 金额: $ 98.64万
• 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/10696230
• 关键词: Ablation; Acceleration; 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; Triage; Unnecessary Procedures; Vaccinated; Vaccination; Visit; Visual; Woman; World Health Organization; acceptability and feasibility; automated visual evaluation; 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; timeline

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.

项目总结 2018年，世界卫生组织(世卫组织)呼吁采取行动，实现全球消除 宫颈癌。成员国于2020年8月批准了一项实现这一目标的战略。世卫组织的计划呼吁 对于人类乳头瘤病毒(HPV)的疫苗接种、筛查和治疗的积极方法， 宫颈癌的单一原因。在低收入和中等收入国家(LMIC)，它们承担了90%的发病率 和全球宫颈癌死亡率，估计这些目标要到2120-a才能实现。 从现在起一个世纪后。缩短这一时间线的一种方法是通过HPV自我采样和立即治疗 那些患侵袭性疾病风险最高的人。这将只能通过一个 易于现场使用的低成本、有效的测试，结合引导妇女的分诊策略 治疗，但避免不必要的程序，消耗有限的资源。改良的AmpFire®HPV 基因分型测试(Atila BiosSystems，CA)是一种新的测试，它可以识别13种高危HPV类型，并对它们进行分层 按致癌风险分为四组。AmpFire®依赖于环介导的等温放大(LAMP)，而不是 比DNA提取更简单，因此可以在1-2小时内以较低的样本成本进行小批量处理。没有其他人了 HPV检测具有这些特点，这使得开发当天筛查和治疗策略成为可能 这可以对风险最高的妇女进行分类，减少随访的损失，并减少过度治疗。此外， 改良的AmpFire®在自我采集的样品中表现出高灵敏度。本研究的目的是 为了评价其在检测高级别癌前病变(宫颈上皮内瘤变， 2级或更高，或CIN2+)。我们还将使用AmpFire®和 自动视觉评估(AVE)，一种基于评估的人工智能分类方法 用普通智能手机拍摄的宫颈图像。因此，本研究将完成以下具体工作 目标： 具体目标1：评估自我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 使用自我采样的改良AmpFire®筛查平台的方法；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 其次是使用自动视觉评估(AVE)进行分类，与洪都拉斯当前的战略进行比较。