Automated Digital Imaging for Cervical Cancer Screening

用于宫颈癌筛查的自动数字成像

• 批准号: 10082877
• 负责人: Louise Kuhn
• 金额: $ 55.51万
• 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/10082877
• 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; 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; 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： 宫颈癌筛查计划对于减少妇女宫颈癌仍然是必不可少的，尽管 人类乳头瘤病毒(HPV)疫苗的可用性。筛查对所有女性都很重要 但对于携带艾滋病毒的妇女来说尤其重要，因为在这个地区HPV的高流行率 尽管接受了抗逆转录病毒治疗，但与病情进展相关的风险。在这里我们 建议研究一种新的宫颈自动数字成像方法的临床应用 在MobileODT平台上作为一种屏幕和处理方法。我们建立在长期合作的基础上 开普敦大学和哥伦比亚大学之间的合作研究如何加强 南非的宫颈癌筛查和治疗。目前，筛选和款待节目 世界卫生组织推荐使用HPV DNA检测。我们有 证明了这种方法在南非的安全性、有效性和成本效益 在妇女中艾滋病毒感染率很高的背景下。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检测的可行性和出色的性能 这可以在一次访问、筛选和治疗计划的护理点使用。在这里，我们建议 将这项工作扩展到具体目标1：自动化的性能特征 数字成像作为一种独立的初步筛查测试，以取代HPV DNA测试，用于 一次访问、筛选和处理方法；具体目标2： 自动数字成像作为筛查HPV DNA阳性女性的分诊测试- 和具体目标3：设施一级的业务挑战和促进者 将这种新的成像技术集成到一次访问的屏幕和治疗程序中。我们建议 在感染和未感染艾滋病毒的妇女中进行研究，以达到这些目标 南非开普敦的临床站点。我们的总体目标是加强宫颈癌的治疗 筛查方法，降低筛查成本，提高筛查效果。