Validation of a lab-free low-cost screening test for prevention of cervical cancer: automated visual evaluation

项目总结/摘要 人工智能（AI）有可能通过提高生产力，减少人类 错误，并协助诊断和治疗。图像分类算法可用于开发 自动视觉评估（AVE）：在低和高风险人群中预防宫颈癌的潜在改变者 中等收入国家（LMIC）。AVE技术读取宫颈的数字照片以提供诊断 和治疗建议。AVE是一种真正的护理点测试，成本低，不需要 实验室AVE可用于单独的初步筛查，或分流HPV阳性的妇女。我们 将比较AVE与LMIC中常见的筛查方法：乙酸目视检查（VIA）和 常规细胞学检查。MobileODT的增强型视觉评估（伊娃）系统是一个云连接的 智能手机平台上的移动的阴道镜。FDA批准并在42个国家使用。MobileODT是 将AVE整合到伊娃系统中的独特优势。 我们的目标是在伊娃平台上验证AVE并将其商业化。第一阶段的目标是使AVE适应 伊娃系统使用最佳神经网络架构，直接在手机上运行或作为云- 基于服务。第二阶段是一项前瞻性临床试验，在El卫生部的站点招募了10，000名患者。 萨尔瓦多。所有筛查阳性的患者和10%的阴性患者将接受阴道镜检查和活检。 将比较AVE作为主要筛选试验与细胞学和VIA的灵敏度。hpv阳性 对于女性，AVE将与VIA进行比较，作为分诊试验。

PROJECT SUMMARY/ABSTRACT Artificial intelligence (AI) has the potential to revolutionize medicine by improving productivity, reducing human error, and assisting with diagnosis and treatment. Image classification algorithms can be used to develop automated visual evaluation (AVE): a potential game-changer for cervical cancer prevention in low- and middle-income countries (LMICs). AVE technology reads digital photographs of a cervix to provide diagnosis and treatment recommendations in seconds. AVE is a true point of care test, low cost and does not require a laboratory. AVE could be used either for stand-alone primary screening, or to triage HPV-positive women. We will compare AVE to common screening methods in LMICs: visual inspection with acetic acid (VIA) and conventional cytology. Enhanced Visual Assessment (EVA) System by MobileODT is a cloud-connected mobile colposcope on a smartphone platform. It is FDA cleared and used in 42 countries. MobileODT is uniquely poised to integrate AVE into the EVA System. Our aim is to validate and commercialize AVE on the EVA platform. Phase I aims will adapt AVE to run on the EVA system using an optimal neural network architecture, running either directly on the phone or as a cloud- based service. Phase II is a prospective clinical trial of 10,000 patients recruited at ministry of health sites in El Salvador. All screen-positive patients, and 10% of negative patients, will undergo colposcopy with biopsy. Sensitivity of AVE as a primary screening test will be compared to cytology and to VIA. In HPV-positive women, AVE will be compared to VIA as a triage test.