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; 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.

项目摘要 2018年，世界卫生组织（WHO）呼吁采取行动实现全球消除 宫颈癌。成员国在2020年8月实现了这一目标的策略。 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， 宫颈癌的唯一原因。在低收入和中等收入国家（LMIC）中，有90％的事件 以及全球宫颈癌的死亡率，据估计，直到2120年才能达到这些目标 - 从现在开始。缩短该时间表的一种方法是通过HPV自抽采样和立即治疗 患有侵入性疾病的风险最高的人。这只会通过 在现场易于使用的低成本和有效测试，结合了传播女性的分类策略 治疗但避免不必要的程序耗尽有限的资源。修改的AMPFIRE®HPV 基因分型测试（Atila Biosystems，CA）是一种新的测试，可识别13种高风险HPV类型并对其进行分层 通过致癌风险分为四组。 AMPFIRE®依靠循环介导的等温扩增（LAMP）而不是 比DNA提取，因此可以在1-2小时内以每个样品成本低的成本进行小批量处理。没有其他 HPV测试具有这些特征，可以制定当天的屏幕和治疗策略 这可以使妇女处于最高风险，减少随访的损失并减少过度治疗。此外， 修改后的AMPFIRE®在自收集的样品中表现出很高的灵敏度。这项研究的目的是 为了评估检测高级预科剂（宫颈上皮内肿瘤， 2年级或更高级，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 用普通智能手机捕获的宫颈图像。那将完成以下特定的研究 目标： 特定目的1：估计自我和提供商的测试性能经过修改 洪都拉斯的Ampfire®筛选平台；特定目的2：评估一次访问的可行性 使用自采样的修改AMPFIRE®筛选平台的方法；特定目标3：评估 使用修改AMPFIRE®测试的当天屏幕和治疗方法的成本效益 然后进行自动视觉评估（AVE）与洪都拉斯当前策略的分类。