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

• 批准号: 10450160
• 负责人: Elizabeth Chiao
• 金额: $ 84.38万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 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/10450160
• 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

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.

项目摘要/摘要 我们最近报告说，SCCA事件（尤其是晚期疾病）和死亡率是 50岁以上的女性迅速增加（每年> 3％），著名的女性（> 5％）增加 表明SCCA是所有人中癌症事件和死亡率最快的加速原因之一 癌地点。生殖道（宫颈/阴道/外阴）发育不良或癌症（WLGTN）的妇女代表 大量人口（每年> 200,000例新案件），患有SCCA的风险升高。我们和其他人有 表明，在50岁及以上的WLGTN中，SCCA的事件超过20人， 这两者都与艾滋病毒女性的事件率相当（这是当前筛查的重点 努力），与宽度筛查之前的宫颈癌事件相似。此外，HPV 由于WLGTN已经 暴露于致癌的HPV，在美国女性中，疫苗率仍然很低。这突出了紧急 需要以肛门癌筛查形式评估可能有针对性预防的研究。我们的目标是 评估WLGTN中SCCA筛查的益处和危害。 SCCA的筛选涉及 使用癌前肛门病变（使用高级鳞状上皮内病变或“ Ahsils”）鉴定 细胞学测试或HPV测试（患者本身可能执行）。这些病变（如果在组织学上 然后可以治疗确认），从而防止癌发育，类似于广泛的做法 认可宫颈癌。为了告知指南，有关筛查特征，自然历史的数据， 患者可接受性，益处和危害以及WLGTN中SCCA筛查的成本效益， 迫切需要。因此，我们提出了350名未感染的350 HIV的两年一年的纵向研究 WGLTN年龄≥45岁。这项纵向研究的结果将用于合成数学 （仿真）将估算临床和人口水平的收益与危害和成本效益的模型 与不同的筛选方法相关。具体目的是：（1a）评估相关性 肛门细胞学，临床收集和自我收集的高风险HPV（HRHPV）的筛查测试特征 与高分辨率抗检查金标准（HRA）检查的金标准相比 进行活检； （1b）：确定基线肛门HRHPV和组织学AHSIL（HAHSIL）患病率和 WLGTN的纵向风险； （2）：比较患者的可接受性和肛门癌的经验 WLGTN筛选策略； （3）：开发一个数学模型来确定潜力 肛门发育不全筛查和/或HRHPV的死亡率和发病率益处，危害和成本效益 在WLGTN中进行测试。总而言之，拟议的多学科研究将产生有关的急需数据 WLGTN的最佳SCCA筛选方法，需要为国家筛查建议提供必要 对于wlgtn。这项研究将对临床癌症预防实践有直接影响。