Automated Digital Imaging for Cervical Cancer Screening

用于宫颈癌筛查的自动数字成像

• 批准号: 10210372
• 负责人: Louise Kuhn
• 金额: $ 51.9万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-06 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10210372
• 关键词: Acetic Acids; Address; Algorithms; Automobile Driving; Biological Assay; Biopsy; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Cervix Uteri; Characteristics; Classification; Clinical; Collaborations; Colposcopes; Colposcopy; Cytology; Data Analyses; Development; Diagnosis; Effectiveness; FDA approved; General Population; Generations; Goals; Gold; HIV; Health Services; High Prevalence; Histologic; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Image; Imaging technology; Incidence; India; Infrastructure; Investigation; Lesion; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Methods; Modeling; Morbidity - disease rate; Output; Performance; Predictive Value; Prevalence; Price; Primary Prevention; Procedures; Provider; Randomized Clinical Trials; Reporting; Resources; Risk; Safety; Secondary Prevention; Sensitivity and Specificity; Services; South Africa; South African; Specificity; Testing; Time; Triage; Universities; Visit; Visual; Woman; Women' s Group; Work; World Health Organization; antiretroviral therapy; automated visual evaluation; base; clinical research site; cloud based; cost; cost effective; cost effectiveness; digital; digital imaging; effectiveness study; high risk population; histological specimens; improved; low and middle-income countries; machine learning algorithm; mortality; new technology; point of care; programs; recruit; screening; screening program; screening services; success; viral DNA

Project Abstract/Summary: Cervical cancer screening programs remain essential to reduce cervical cancer in women despite the availability of human papilloma virus (HPV) vaccines. Screening is important for all women but is particularly important for women living with HIV given the high prevalence of HPV in this group and risks associated with progression notwithstanding antiretroviral therapy. Here we propose to investigate the clinical utility of a new method of automated digital imaging of the cervix on the MobileODT platform as a screen-and-treat approach. We build on a long-term collaboration between the University of Cape Town and Columbia University investigating how to strengthen cervical cancer screening and treatment in South Africa. Currently, screen-and-treat programs utilizing HPV DNA testing are recommended by the World Health Organization. We have demonstrated the safety, efficacy and cost-effectiveness of this approach for the South African setting with its high HIV prevalence in women. In this setting, we are currently completing an NCI- supported study demonstrating the feasibility and outstanding performance of an HPV DNA assay that can be used at the point-of-care for a single-visit, screen-and-treat program. Here we propose to extend this work to investigate in Specific Aim 1: the performance characteristics of automated digital imaging as a standalone, primary screening test to replace HPV DNA testing for use in the single-visit, screen-and-treat approach; Specific Aim 2: the performance characteristics of automated digital imaging as a triage test for women who test HPV DNA positive in the screen- and-treat approach; and Specific Aim 3: facility-level operational challenges and facilitators to integrating this new imaging technology into single-visit screen-and-treat programs. We propose to undertake the studies to address these aims among women living with and without HIV at clinical sites in Cape Town, South Africa. Our overall goal is to strengthen cervical cancer screening approaches to reduce cost and improve the effectiveness of screening.

项目摘要/摘要： 尽管 人乳头瘤病毒（HPV）疫苗的可用性。筛查对所有女性都很重要 但鉴于HPV的高流行，对于艾滋病毒妇女尤为重要 尽管有抗逆转录病毒疗法，但与进展有关的组和风险。我们在这里 建议研究子宫颈自动化数字成像的新方法的临床实用性 在MobileDT平台上作为屏幕和治疗方法。我们以长期合作为基础 在开普敦大学和哥伦比亚大学之间调查如何加强 南非的宫颈癌筛查和治疗。目前，屏幕和处理程序 世界卫生组织建议使用HPV DNA测试。我们有 证明了这种方法对南非的安全性，功效和成本效益 以其女性的艾滋病毒率高而设定。在这种情况下，我们目前正在完成NCI- 支持的研究证明了HPV DNA分析的可行性和出色性能 可以在单访，屏幕和治疗程序的临界点上使用。我们在这里提出 扩展这项工作以在特定目标中进行调查1：自动化的性能特征 数字成像作为独立的主要筛选测试，以取代HPV DNA测试以用于 单访问，屏幕和治疗方法；特定目标2：性能特征 自动数字成像作为分类测试，用于在屏幕中测试HPV DNA阳性的女性 和治疗方法；和特定目标3：设施级的运营挑战和促进者 将这种新成像技术集成到单访问的屏幕和处理程序中。我们建议 进行研究以解决与艾滋病毒的妇女之间的这些目标 南非开普敦的临床场所。我们的总体目标是增强宫颈癌 筛选方法降低成本并提高筛查的有效性。