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 感染者高度上皮内病变 (HSIL) 诊断中的有效性

• 批准号: 10058207
• 负责人: Sharmila Anandasabapathy
• 金额: $ 63.76万
• 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/10058207
• 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; 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。 HIV感染者发生SCCA的风险是一般人的40-80倍 最近的队列研究报告称，HIV 感染男性中 SCCA 的发生率介于 49-144/10万人年，远高于之前的宫颈癌发病率 宫颈细胞学检查的广泛筛查。 HIV 感染者中肛门癌前病变和癌症的惊人增加 受感染的个体导致人们更加重视预防。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协会） 建议每年进行肛门细胞学筛查，并在高分辨率肛门镜 (HRA) 引导下进行活检 HIV感染男性发生性行为时肛门高度上皮内病变（HSIL）的组织学证实 男性（MSM）和某些感染艾滋病毒的女性。然而，HRA 指导下的 HSIL 组织学诊断是 资源密集，并且有几个缺点，包括：广泛的临床医生专业知识/培训；病理费用， 可用性、口译专业知识；单独就诊进行诊断和治疗；以及患者的不适 鉴于基于 HRA 的视觉 HSIL 特异性较低，与不必要的非肿瘤性活检相关 鉴别。我们小组开发了一种便携式、电池供电、高分辨率显微内窥镜 (mHRME)，提供肛门上皮的亚细胞图像，描绘细胞和形态 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 当前 HRA 引导活检标准的效率、临床影响和成本效益。在最近的一次 试点试验中，mHRME 表现出肛门 HSIL 诊断的高敏感性和特异性（94% 和 92%） 分别）与肛门活检相比。根据我们重要的初步数据，我们现在建议优化 并通过提供实时图像解释的软件界面验证 3D 成像和 HRME 援助，从而促进经验不足的临床医生在社区或资源匮乏的环境中使用。 为了验证这一点，我们将进行一项研究，以确定诊断的效率和诊断特征 mHRME“光学活检”方法与当前基于 HRA 的组织活检标准的比较。此外，我们将 使用 mHRME 构建、完善和分析基于 HRA 的筛查疾病模型，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 提高艾滋病毒感染者肛门癌筛查的功效和资源利用率 其他上皮癌，包括子宫颈癌、口腔癌、膀胱癌和胃肠道癌。