The Effectiveness of High Resolution Microendoscopy (HRME) in High Grade Intraepithelial Lesions (HSIL)Diagnosis for People Living with HIV

高分辨率显微内窥镜 (HRME) 在 HIV 感染者的高级上皮内病变 (HSIL) 诊断中的有效性

• 批准号: 10523516
• 负责人: Sharmila Anandasabapathy
• 金额: $ 62.85万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-12-18 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10523516
• 关键词: 3-Dimensional; AIDS prevention; Adoption; Age; Aging; Algorithms; Anal canal; Anus; Area; Biopsy; Bladder; Bronchi; Cancer Prevention Trial; Cancerous; Carcinoma; Cervical; Cervix Uteri; Characteristics; Clinical; Cohort Studies; Colon; Communicable Diseases; Communities; Computer software; Costs and Benefits; Cytology; Data; Detection; Development; Diagnosis; Diagnostic; Disease; Disease model; Documentation; Effectiveness; Epithelium; Esophagus; Evaluation; Gastrointestinal tract structure; General Population; Goals; Guidelines; HIV; Histologic; Histology; Image; Image Analysis; Improve Access; Incidence; Individual; Lesion; Malignant Neoplasms; Malignant Squamous Cell Neoplasm; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Maps; Mathematics; Medical; Morphology; Neoplasms; New York; Nuclear; Optical Biopsy; Optics; Oral cavity; Pathology; Patients; Performance; Persons; Pleomorphism; Population; Predictive Value; Prevention; Primary Care; Procedures; Quality-Adjusted Life Years; Recommendation; Reporting; Resolution; Resource-limited setting; Resources; Risk; Screening for cancer; Sensitivity and Specificity; Societies; Specificity; Squamous intraepithelial lesion; Stomach; Technology; Testing; Three-Dimensional Image; Three-Dimensional Imaging; Time; Tissues; Training; Triage; United States; Visit; Visual; Woman; accurate diagnosis; automated image analysis; cancer clinical trial; cancer prevention; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; experience; follow-up; high risk; high standard; improved; innovation; intraepithelial; men; men who have sex with men; microendoscope; microendoscopy; models and simulation; new technology; novel; pilot trial; portability; premalignant; procedure cost; real-time images; screening; screening program; standard of care

Squamous cell cancer of the anus (SCCA) is one of the most common cancers among aging HIV-infected individuals in the United States. HIV-infected persons are at 40-80-times higher risk for SCCA than the general population, and recent cohort studies report that the incidence of SCCA among HIV-infected men is between 49-144/100,000 person-years, which is substantially higher than the incidence of cervical cancer prior to widespread screening with cervical cytology. The alarming increase in anal precancer and cancer in HIV- infected individuals has led to an increased emphasis on prevention. Current HIV primary care Guidelines (NY state HIV primary care guidelines, HIV Medical Association, and Infectious Diseases Society of America) both recommend annual anal cytology screening, with triage to high resolution anoscopy (HRA)-guided biopsy for histologic confirmation of anal high grade intraepithelial lesions (HSIL) among HIV-infected men who have sex with men (MSM), and certain HIV-infected women. However, HRA-guided histologic diagnosis of HSIL is resource intensive, and has several drawbacks, including: extensive clinician expertise/training; pathology cost, availability, interpretation expertise; separate patient visits for diagnosis and treatment; and patient discomfort associated with unnecessary, non-neoplastic biopsies, given the low specificity of HRA-based visual HSIL identification. Our group has developed a portable, battery-operated, high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. Our central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of HRA-guided biopsy. In a recent pilot trial, the mHRME demonstrated a high sensitivity and specificity of anal HSIL diagnosis (94% and 92% respectively) compared to anal biopsy. Based on our significant preliminary data, we now propose to optimize and validate 3D imaging and HRME with a software interface that provides real- time image interpretation assistance, thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, we will conduct a study to determine the efficiency and diagnostic characteristics of an mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. In addition, we will construct, refine and analyze a disease model of HRA-based screening with mHRME to determine the cost- effectiveness of incorporating HRME into HRA-based HSIL diagnosis. Successful results will allow for improved efficacy and resource utilization for cancer screening in HIV-infected individuals for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.

肛门（SCCA）的鳞状细胞癌是衰老的HIV感染者中最常见的癌症之一 在美国的个人。 HIV感染者的SCCA风险高40-80倍 人口和最近的队列研究报告说，艾滋病毒感染男性中SCCA的发病率是 49-144/100,000人年，其大幅高于宫颈癌的发病率 用宫颈细胞学进行广泛的筛查。 HIV- 受感染的个体导致人们对预防的重视程度越来越高。当前的HIV初级保健指南（纽约州 州艾滋病毒初级保健指南，艾滋病毒医学协会和美国传染病学会）均 推荐年度肛门细胞学筛查，分类至高分辨率隔离（HRA）指导活检 肛门高级上皮内病变（HSIL）的组织学证实 与男性（MSM）和某些感染HIV的妇女。但是，HRA引导的HSIL组织学诊断是 资源密集型，有几个缺点，包括：广泛的临床医生专业知识/培训；病理成本， 可用性，解释专业知识；单独的患者就诊和治疗；和患者不适 鉴于基于HRA的视觉HSIL的特异性较低，与不必要的非肿瘤活检有关 鉴别。我们的小组已经开发了一种便携式，电池操作的高分辨率微型镜镜 （MHRME）提供肛门上皮的亚细胞图像，描述细胞和形态学 与肿瘤有关的变化。我们的核心假设是，这种“光学”方法将增加 HRA引导活检的当前标准的效率，临床影响和成本效益。在最近的一个 试点试验，MHRME表现出肛门HSIL诊断的高灵敏度和特异性（94％和92％ 分别与肛门活检相比。基于我们重要的初步数据，我们现在建议优化 并使用提供实时图像解释的软件接口验证3D成像和HRME 援助，从而促进了经验不足的临床医生在社区或低资源环境中的使用。 为了验证这一点，我们将进行一项研究，以确定 MHRME“光学活检”方法与基于HRA的组织活检的当前标准。此外，我们将 用MHRME构建，完善和分析基于HRA的疾病模型，以确定成本 将HRME纳入基于HRA的HSIL诊断的有效性。成功的结果将允许 改善了艾滋病毒感染者肛门癌和癌症筛查的疗效和资源利用 其他上皮癌，包括子宫颈，口腔，膀胱和胃肠道。

项目成果

p16 Immunoreactivity Correlates With Morphologic Diagnosis of HPV-associated Anal Intraepithelial Neoplasia: A Study of 1000 Biopsies.

p16 免疫反应性与 HPV 相关肛门上皮内瘤变的形态学诊断相关：1000 个活检组织的研究。

• DOI: 10.1097/pas.0000000000001769
• 发表时间: 2021
• 期刊: The American journal of surgical pathology
• 作者: Liu,Yuxin;McCluggage,WGlenn;Darragh,TeresaM;Farhat,Nada;Blakely,Morgan;Sigel,Keith;Zheng,Wenxin;Westra,WilliamH;Gaisa,MichaelM
• 通讯作者: Gaisa,MichaelM