The effectiveness of screening women with lower genital tract neoplasia or cancers for anal cancer precursors

对患有下生殖道肿瘤或癌症的女性进行肛门癌前兆筛查的有效性

基本信息

批准号：
10298753
负责人：
Elizabeth Chiao
金额：
$ 91.6万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10298753
关键词：
Age-Years Anal carcinoma Anus Biological Markers Biopsy Cancer Etiology Carcinoma Cervical Cervical Cancer Screening Characteristics Clinical Clinical Trials Clinical assessments Cytology Data Decision Analysis Development Disease Dysplasia Effectiveness Epidemiology Exposure to Generations Goals Gold Guidelines HIV HPV-High Risk Healthcare Histologic Human Papilloma Virus Vaccination Human Papilloma Virus Vaccine Human Papillomavirus Human papilloma virus infection Incidence Lesion Longitudinal Studies Malignant Neoplasms Malignant neoplasm of anus Malignant neoplasm of cervix uteri Malignant neoplasm of vulva Mathematics Methods Modality Modeling Morbidity - disease rate Natural History Neoplasms Oncogenic Patients Performance Persons Population Prevalence Prevention Prevention Guidelines Preventive measure Provider Publishing Recording of previous events Registries Reporting Resolution Resources Risk Screening for cancer Sensitivity and Specificity Site Squamous cell carcinoma Squamous intraepithelial lesion Testing Vagina Vulval intraepithelial neoplasia Woman age group aged cancer prevention cancer site comparative cost cost effective cost effectiveness disease natural history evidence based guidelines experience high risk population high standard improved mathematical model mortality multidisciplinary patient-level barriers premalignant prevent prospective reproductive tract screening screening guidelines simulation

项目摘要

PROJECT SUMMARY/ABSTRACT We recently reported that SCCA incidence (particularly advanced-stage disease) and mortality rates are increasing rapidly (>3% per year) in the US with notable (>5%/year) increases in women 50 years and older showing that SCCA is one of the fastest accelerating causes of cancer incidence and mortality among all cancer sites. Women with lower genital tract (cervical/vaginal/vulvar) dysplasia or cancer (WLGTN) represent a large population (>200,000 new cases per year) at elevated risk of developing SCCA. We and others have shown that the incidence of SCCA among WLGTN aged 50 years and older is over 20 per 100,000 persons, which is both comparable to the incidence rate among women with HIV (who are the focus of current screening efforts) and is similar to the cervical cancer incidence prior to widespread screening. Furthermore, HPV vaccination is unlikely to decrease SCCA incidence in this population both because WLGTN have already been exposed to oncogenic HPV, and vaccine rates remain low among US women. This highlights an urgent need for studies evaluating possible targeted prevention in the form of anal cancer screening. Our goal is to evaluate the benefits and harms of SCCA screening among WLGTN. Screening for SCCA involves the identification of precancerous anal lesions (high-grade squamous intraepithelial lesions or "aHSILs") using cytologic testing or HPV testing (potentially performed by patients themselves). These lesions (if histologically confirmed) can then be treated, thereby preventing carcinoma development, similar to practices widely endorsed for cervical cancer. To inform guidelines, data regarding screening characteristics, natural history, patient acceptability, the benefits and harms, and cost-effectiveness of screening for SCCA among WLGTN, are urgently needed. We therefore propose a two-site, two-year longitudinal study of 350 HIV uninfected WGLTN aged ≥45 years. The results of this longitudinal study will be used to synthesize a mathematical (simulation) model that will estimate clinical and population-level benefits versus harms and cost-effectiveness associated with different screening approaches. The Specific Aims are: (1A) To evaluate the respective screening test characteristics of anal cytology, clinician-collected and self-collected high-risk HPV (hrHPV) testing, and cytology/hrHPV cotesting compared to the gold standard of high-resolution anoscopy (HRA) exam with biopsy; (1B): To determine baseline anal hrHPV and histologic aHSIL (haHSIL) prevalence and longitudinal risk among WLGTN; (2): To compare patient acceptability and experiences for anal cancer screening strategies among WLGTN; and (3): To develop a mathematical model determining the potential mortality and morbidity benefits, harms, and cost-effectiveness of anal dysplasia screening and/or hrHPV testing in WLGTN. In summary, the proposed multidisciplinary study will generate much-needed data regarding the optimal SCCA screening approach for WLGTN, necessary to inform national screening recommendations for WLGTN. This study will have direct implications for clinical cancer prevention practices.

项目概要/摘要我们最近报道 SCCA 发病率（特别是晚期疾病）和死亡率在美国快速增长（每年 >3%），其中 50 岁及以上女性的增长显着（每年 >5%）表明 SCCA 是所有癌症发病率和死亡率增长最快的原因之一患有下生殖道（宫颈/阴道/外阴）发育不良或癌症（WLGTN）的女性代表了癌症部位。大量人口（每年超过 200,000 例新病例）罹患 SCCA 的风险较高。研究表明，50 岁及以上 WLGTN 中 SCCA 的发病率超过每 10 万人中 20 人，这与女性艾滋病毒感染者（目前筛查的重点）的发病率相当。）并且与广泛筛查之前的宫颈癌工作类似。此外，HPV。疫苗接种不太可能降低该人群中 SCCA 的发生率，因为 WLGTN 已经暴露于致癌 HPV 的美国女性的疫苗接种率仍然很低，这凸显了一个紧迫的问题。需要进行研究以评估肛门癌筛查的可能针对性预防。评估 WLGTN 中 SCCA 筛查的益处和危害 SCCA 筛查涉及以下内容。使用以下方法识别癌前肛门病变（高级鳞状上皮内病变或“aHSIL”）细胞学检测或 HPV 检测（可能由患者自己进行）。已证实），然后可以进行治疗，预防癌症的发展，类似于广泛的做法为宫颈癌提供指导、有关筛查特征、自然史的数据， WLGTN 中 SCCA 筛查的患者可接受性、益处和危害以及成本效益，因此，我们迫切需要对 350 名未感染艾滋病毒的人进行一项为期两年的两地纵向研究。 WGLTN 年龄≥45 岁。这项纵向研究的结果将用于综合数学。（模拟）模型将估计临床和人群水平的益处与危害以及成本效益与不同筛选方法相关的具体目标是： (1A) 评估各自的筛选方法。肛门细胞学、临床医生采集和自行采集的高危型 HPV (hrHPV) 筛查测试特征检测和细胞学/hrHPV 联合检测与高分辨率肛门镜 (HRA) 检查的黄金标准相比通过活检；(1B)：确定基线肛门 hrHPV 和组织学 aHSIL (haHSIL) 患病率和 (2): 比较患者对肛门癌的接受度和经历 WLGTN 中的筛选策略；以及 (3)：开发确定潜力的数学模型肛门发育不良筛查和/或 hrHPV 的死亡率和发病率益处、危害和成本效益总之，拟议的多学科研究将产生急需的数据。 WLGTN 的最佳 SCCA 筛查方法，对于告知国家筛查建议是必要的这项研究将对临床癌症预防实践产生直接影响。