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: 10311046
• 负责人: Sharmila Anandasabapathy
• 金额: $ 63.42万
• 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 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10311046
• 关键词: 3-Dimensional; AIDS prevention; Adoption; Age; Aging; Algorithms; Americas; Anal canal; Anus; Area; Biopsy; Bladder; Bronchi; Cancerous; Carcinoma; Cellular Morphology; Cervical; Cervix Uteri; Characteristics; Clinical; Cohort Studies; Colon; Communicable Diseases; Communities; Computer software; Costs and Benefits; Cytology; Data; Detection; Development; Diagnosis; Diagnostic; Disease model; Documentation; Effectiveness; Epithelial; Esophagus; Evaluation; Gastrointestinal tract structure; General Population; Goals; Gold; 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; Neoplasms; New York; Nuclear; Optical Biopsy; Optics; Oral cavity; Pathology; Patients; Performance; Persons; Pleomorphism; Population; Predictive Value; Prevention; Primary Health Care; Procedures; Quality-Adjusted Life Years; 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; base; 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.

肛门鳞状细胞癌（SCCA）是老年HIV感染者中最常见的癌症之一， 在美国的个人。艾滋病毒感染者患SCCA的风险比一般人高40-80倍。 最近的队列研究报告称，HIV感染男性中SCCA的发病率在 49-144/100，000人-年，这大大高于2010年以前的宫颈癌发病率。 广泛进行子宫颈细胞学检查。艾滋病患者肛门癌前病变和癌症的惊人增长- 感染者人数的增加使人们更加重视预防。现行艾滋病毒初级保健指南（纽约 州艾滋病初级保健指南、艾滋病医学协会和美国传染病学会） 建议每年进行一次肛门细胞学筛查，并对高分辨率肛门镜（HRA）引导下的活检进行分类， 有性行为HIV感染男性肛门高度上皮内病变（HSIL）的组织学证实 男男性行为者（MSM）和某些感染艾滋病毒的妇女。然而，HRA引导的HSIL组织学诊断是 资源密集型的，并且具有几个缺点，包括：广泛的临床医生专业知识/培训;病理学成本， 可用性、口译专业知识;诊断和治疗的单独患者访视;以及患者不适 与不必要的非肿瘤性活检相关，因为基于HRA的视觉HSIL的特异性较低 识别.我们的小组已经开发出一种便携式，电池供电，高分辨率的显微内窥镜 （mHRME），提供肛门上皮的亚细胞图像，描绘细胞和形态学 与肿瘤相关的变化。我们的中心假设是，这种“光学”方法将增加 目前HRA引导活检标准的效率、临床影响和成本效益。在最近的一 初步试验表明，mHRME对肛门HSIL诊断具有较高的敏感性和特异性（94%和92%）， 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 并通过提供真实的图像解释的软件界面验证3D成像和HRME 帮助，从而促进经验不足的临床医生在基于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，以确定效率和诊断特征的一个 mHRME“光学活检”方法与当前基于HRA的组织活检标准。此外，我们将 构建、完善和分析基于mHRME的HRA筛查疾病模型，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 提高HIV感染者肛门癌筛查的有效性和资源利用率， 其他上皮癌，包括宫颈癌、口腔癌、膀胱癌和胃肠道癌。